Healy frequency device

1. Introduction

Version followed: the Healy wearable microcurrent device and its companion app as Healy World GmbH and Healy GmbH publish it, with US status as recorded under FDA 510(k) K191075 and Australian status as recorded by the TGA. The psychotherapist works alongside this method and does not use, sell, prescribe or recommend the device. The guide covers the therapist's own work when a client uses, is considering, or sells a Healy.

What it is. Healy is a small battery-powered unit that clips to clothing, pairs with a smartphone app and delivers "frequency-modulated microcurrent programs" to the body through adhesive electrodes [source: Healy app store listing, developer Healy World GmbH; Rolling Stone]. Marcus Schmieke, who launched the larger TimeWaver system in 2007, is described as the inventor and developer of both the Healy and TimeWaver products [source: Rolling Stone; BehindMLM review quoting the company site]. The device is sold through multi-level marketing (MLM) by Healy World [source: McGill OSS; BehindMLM; Rolling Stone].

Core idea of change, as the company states it. According to the company, Healy delivers individualised microcurrent frequencies ("IMF") that support "harmonization of the bioenergetic field". In its account, small currents restore the body's own frequencies and correct cellular "imbalances" or cell-membrane voltage. The company draws on Robert O. Becker's The Body Electric (1985) and on Björn Nordenström's work [source: Rolling Stone; McGill OSS; BehindMLM]. Higher-priced editions are said to choose "personalised" frequencies from a scan of the user [source: McGill OSS]. This guide reports these as the company's concepts. It does not state them as fact and does not dismiss them.

Regulatory status (one line each):

• USA: FDA 510(k) clearance K191075, 22 November 2019, to TimeWaver Production GmbH, as an over-the-counter Class II transcutaneous electrical nerve stimulator for pain relief (21 CFR 882.5890; product code NUH). The cleared indications are temporary relief of muscle soreness from exercise or household work, chronic intractable pain, and arthritis pain. Clearance means "substantially equivalent" to an existing TENS device, not FDA approval, and it does not cover the app programs' wider claims [source: FDA 510(k) record via Innolitics; AccessGUDID; McGill OSS; BehindMLM FDA article].
• Australia: ARTG entry 336551, "Analgesic TENS system" (Healy World Australia Pty Ltd), is listed as cancelled under s41GL(d) of the Therapeutic Goods Act [source: TGA cancellation notice; date and reasons not shown]. Separately, the TGA issued two infringement notices totalling $26,640 for advertising the TENS device for purposes outside its ARTG entry, including references to depression, anxiety and related sleep disturbance without permission [source: TGA notice].
• European Union: the company describes Healy as a Class IIa medical device. A news report repeats the company's statement that its EU certification extends to depression and anxiety [source: BehindMLM; Rolling Stone] [uncertain: notified-body certificate and intended-purpose wording not verified]. This is the company's claim; no source cited here shows the device treats depression or anxiety.
• UK and Canada: [uncertain: not verified].

Evidence status (one line): the company cites an internal, company-sponsored study of 249 participants for back and skeletal pain. No independent peer-reviewed evidence supports the frequency, bioenergetic-field or disease claims made for the programs [source: Rolling Stone; McGill OSS].

Who uses and sells it. Healy is mostly bought by consumers. Healy World said it had about 300,000 consumers, roughly 10% of whom sell the device. Sellers move up through ranks based on recruitment and downline volume, and much promotion happens on social media through influencers [source: Rolling Stone]. Some complementary practitioners also use it with clients [uncertain: not verified]. Device editions are priced in the hundreds to thousands of dollars or euros, with programs and app subscriptions sold separately [source: McGill OSS; BehindMLM; Rolling Stone].

2. Framework

How a client meets and uses the device, as published. The client usually hears of Healy through a friend, an influencer or a distributor. They buy an edition through a member or distributor link, pair the device with the app, attach electrodes and start programs from the app library. The library is grouped into categories such as pain, stress, sleep, energy balance, beauty and chakras [source: app store listing; Rolling Stone]. Higher editions add the company's "personalised" program selection [source: McGill OSS]. Buyers can become members and earn commissions under a binary-and-matching compensation plan with twelve ranks [source: BehindMLM review]. This guide gives no program names, settings or durations.

The psychotherapist's framework alongside it. None of the sources describe this; the phases below are [synthesis]. The work is woven into ordinary therapy sessions, not delivered as separate sessions.

3. Guiding principles

• Curiosity before information. Ask what the device means to the client before saying anything about evidence [synthesis; NCCIH: providers who ask keep patients "fully informed"].
• Attribute, don't adjudicate. Describe "frequencies" and the "bioenergetic field" as the company's concepts, so the client neither feels mocked nor hears an endorsement [synthesis].
• Separate the cleared use from the marketed use. In the US, the device is cleared only as a TENS unit for specific pain; the programs' other claims are the company's or sellers' [source: FDA record; McGill OSS].
• Never perform, sell, prescribe or recommend. Do not operate the device, suggest programs, broker purchases or join a downline [synthesis; APA 3.05, 3.06].
• Medical questions go to the medical team. Contraindications, implanted devices and any change to medicines are for the doctor or pharmacist [source: FDA record lists implanted devices as a contraindication; APA 3.09].
• Mental-health claims are your territory. If the device is offered for depression, anxiety or sleep, assess and treat these with established care. Australia's regulator has treated such advertising as outside the device's approved purpose [source: TGA notice].
• Autonomy with safety. The client decides. You act on risk to the client, children or others [synthesis; APA 3.10].
• Money is a clinical topic. Device, program and membership costs, and the client's earnings or losses as a seller, are worth asking about. The FTC notes most MLM participants "make little or no money" [source: FTC blog 2020].
• Stay within competence. Do not interpret device "analyses" or give technical advice [source: APA 2.01, 2.04].
• Document neutrally. Record use, purpose, cost, medical coordination and risk decisions in factual, non-pejorative language [synthesis].

4. Intervention inventory

Everything below is the psychotherapist's own work alongside a client's Healy use. None of it involves operating, choosing programs for, or advising on the device. Where a step is not drawn from a cited source, it is marked [synthesis].

4.1 Routine, non-judgemental inquiry and recording

• Purpose / when: At intake and at reviews, find out whether the client uses complementary devices, remedies or practices. Healy is often bought for stress, sleep or mood, so it overlaps with presenting problems [source: NCCIH tips; app store listing; Rolling Stone].
• Steps:
  1. Add a general question about complementary approaches, including wearable or "frequency" devices, to the intake and review forms [source: NCCIH tips; wording synthesis].
  2. Ask openly in session. Normalise the question as one you ask everyone.
  3. Record the device name, who introduced it, the purpose the client gives, how long they have used it, and whether they also sell it.
  4. Record whether the treating doctor knows about it.
• Example language (illustrative): "I ask everyone about anything else they're using for their health, like supplements, apps or devices. Is there anything like that for you?" / "What do you use the Healy for, in your own words?"
• Watch for: a guarded answer, which may mean the client expects judgement; a device described as replacing medication or treatment; the client being a distributor (see 4.7). It is working when the client discloses freely and returns to the topic unprompted.

4.2 Exploring meaning, hopes and the explanatory model

• Purpose / when: Once use is known, understand what draws the client. Common draws include a sense of control, hope, distrust of medicine, identity, community or income [synthesis, following the Domain XII scope].
• Steps:
  1. Ask the client how they understand the device to work, and reflect it back in their terms ("frequencies", "balancing the field") without endorsing it.
  2. Ask what they hope will change, and how they will know it has.
  3. Ask what led them to it now: a symptom, a failed treatment, a friend or online community, or financial need.
  4. Link the hopes to therapy goals. For example, "sleeping better" or "less anxious" become shared targets you can track.
• Example language (illustrative): "How do you understand what the Healy does?" / "If it worked exactly as you hope, what would be different in a month?" / "What was going on when you first decided to try it?"
• Watch for: hopes that depend on the device curing a physical or psychiatric illness; despair about conventional care; the device as the main link to a social group. It is working when the client can state their hopes and doubts in their own words.

4.3 Clarifying what is claimed, by whom, and what is cleared

• Purpose / when: When the client wants your view, or is making decisions based on claims they have heard. You supply facts, not a recommendation.
• Steps:
  1. Ask permission to share information.
  2. Distinguish three sources of claims:
     • the regulator-cleared use (in the US, a TENS device for specific muscle and arthritis pain);
     • the company's concepts (bioenergetic field, frequencies);
     • sellers' and influencers' claims [source: FDA record; Rolling Stone; McGill OSS].
  3. Mention that FDA clearance means "substantially equivalent" to an existing TENS device, not approval of the programs [source: McGill OSS; BehindMLM].
  4. Note that the company's own site says the device is not intended to "cure, treat, mitigate, diagnose or prevent" disease [source: Rolling Stone].
  5. Ask the client what they make of this.
• Example language (illustrative): "Would it help if I told you what I know about how it's regulated? You can make of it what you like." / "There's what the regulator has cleared it for, what the company says about frequencies, and what sellers say online. Those are three different things."
• Watch for: defensiveness or shame, so slow down and return to 4.2; information overload; a sense that you are campaigning. It is working when the client can tell these three sources apart.

4.4 Supporting an informed, values-based decision

• Purpose / when: When the client is deciding whether to buy, continue, rely on, or sell the device, especially if the decision affects medical or psychological treatment.
• Steps:
  1. Name the decision explicitly.
  2. List the options, including using the device alongside usual care.
  3. Explore values such as autonomy, cost, family views and trust.
  4. Identify what information the client still needs and from whom; medical questions go to the doctor.
  5. Let the client decide. Record the decision and the client's reasons.
  6. Agree a review point. No published decision aid specific to this device was found [uncertain: not verified]; steps are [synthesis].
• Example language (illustrative): "What matters most to you in deciding this?" / "Whatever you decide, I'd like us to keep your doctor in the loop. How would you feel about that?"
• Watch for: your own pressure in either direction; a decision to stop prescribed treatment (go to 4.6 and route to the prescriber). It is working when the client describes the decision as theirs.

4.5 Coordinating with the doctor, prescriber or pharmacist (with consent)

• Purpose / when: Whenever device use affects medical care, or medical facts affect safety. The FDA record lists cardiac pacemakers, implanted defibrillators and other implanted metallic or electronic devices as contraindications [source: FDA 510(k) record]. Questions about pregnancy, epilepsy or other conditions are for the doctor [uncertain: labelling not verified for these].
• Steps:
  1. Explain why coordination helps.
  2. Obtain specific consent for what is shared, with whom, and for what purpose [source: APA 3.10, 4.05].
  3. Prefer a client-led conversation, with a short written note the client can take.
  4. If you contact the team directly, state the facts neutrally (device name, purpose given, any change to treatment) and ask them to advise the client.
  5. Never advise the client yourself on starting, stopping or changing medicines.
• Example language (illustrative): "Could you let your GP know you're using the Healy, especially as you have a pacemaker? They're the right person to check it's safe." / Letter (illustrative): "[Client] has told me they use a wearable microcurrent device marketed as Healy, for sleep and low mood. I'm letting you know with their consent so you can advise them as you see fit."
• Watch for: refusal of consent, which you document while keeping the door open; the client reporting that the doctor dismissed them, which can strengthen distrust (see 5); an implanted device, which is urgent to route. It is working when the medical team is aware and the client feels coordinated rather than reported on.

4.6 Recognising and responding to risk

• Purpose / when: Screen at first disclosure and at reviews. Experts quoted in news reporting warn that the claims may lead people to skip proven treatment and delay diagnosis. Sellers have reportedly claimed benefits for anaphylaxis, autism and a child's brain disease, and reportedly for cancer and dementia [source: Rolling Stone].
• Steps:
  1. Delayed or abandoned care: ask whether the device has replaced any medical, psychiatric or psychological treatment, or delayed seeing a doctor about a new symptom. If so, explore it (4.2), route the client to the doctor or prescriber with consent (4.5), and document. Do not advise on medicines.
  2. Depression, anxiety, sleep: if the device is the client's main response to these, complete your usual assessment, including suicide risk where indicated. Offer established treatment. Australia's regulator found advertising of the device for these conditions to be outside its approved purpose [source: TGA notice].
  3. Children: the company has said the device is not cleared for children [source: Rolling Stone]. If a child is being given the device in place of needed medical care, follow child-safeguarding procedures (4.9). Explore the parent's hopes and fears without blame, and involve the child's doctor.
  4. Pregnancy, implants, epilepsy: route to the doctor. Implanted devices are a listed contraindication [source: FDA record].
  5. Vulnerable adults: sellers may target caregivers of people with dementia [source: Rolling Stone]. Consider adult-safeguarding procedures if a person lacking capacity is being sold or charged for the device.
  6. Financial strain: see 4.7.
• Example language (illustrative): "Has using the Healy changed anything about the other treatment you get, like medication or appointments?" / "Have you mentioned the new chest symptoms to a doctor, or are you seeing whether the device sorts them out first?"
• Watch for: new physical symptoms attributed to "imbalance"; stopping psychiatric medication without the prescriber; a child's symptoms going unassessed. It is working when risky substitutions are surfaced early and medically reviewed.

4.7 Multi-level marketing, money and conflicts of interest

• Purpose / when: When the client sells Healy, is being recruited, or has spent significantly. Healy World pays recruitment and downline commissions across twelve ranks [source: BehindMLM review; Rolling Stone]. The FTC holds MLM companies responsible for distributors' health and earnings claims and notes most participants "make little or no money" [source: FTC blog 2020].
• Steps:
  1. Ask about money spent on devices, programs and subscriptions, and about earnings minus costs, as you would for any financial stressor.
  2. Explore the role of the upline and team: friendship, belonging, pressure, sunk costs.
  3. Help the client compare actual income with expectations. Avoid ridicule.
  4. If the client tries to sell to or recruit you, decline clearly and kindly, and name it as a boundary rather than a judgement [source: APA 3.05, 3.06].
  5. If you are yourself a distributor of any health product, do not treat clients you could sell to, or disclose and resolve the conflict [synthesis; APA 3.06].
• Example language (illustrative): "Can we look at what the Healy business has cost you and what it has brought in so far?" / "I appreciate you thinking of me, but I keep anything I might buy or sell separate from our work. It protects your therapy."
• Watch for: debt, hiding spending from family, pressure to recruit relatives, shame on leaving, and income claims repeated from team calls. It is working when the client can talk about the business in plain numbers and make a choice.

4.8 Health anxiety and somatic symptom presentations

• Purpose / when: When device use is part of a cycle of bodily worry, checking or reassurance. Examples are repeated use after each symptom, frequent checking of "personalised" readings or a wellness watch, or a growing list of "imbalances". Healy's higher editions are said to scan and select frequencies [source: McGill OSS]. The links to health anxiety below are [synthesis].
• Steps:
  1. Map the cycle: trigger, bodily sensation, interpretation, device use or check, short relief, return of the worry.
  2. Treat with established CBT for health anxiety or somatic symptom disorder: formulation, reducing checking and reassurance, behavioural experiments, and attention training (see Domain II).
  3. Agree any change in device use as the client's own experiment. Do not instruct them to stop.
  4. Coordinate with the doctor to avoid duplicate tests.
• Example language (illustrative): "When you notice the sensation and then run a program, what happens to the worry an hour later? And the next day?"
• Watch for: checking that is increasing; new "findings" that create new worries. It is working when checking falls and the client tolerates uncertainty.

4.9 Reporting routes

• Purpose / when: When you meet unlawful advertising, harm, or a safeguarding concern. Reporting is an option for the client and, where duties require, for you.
• Steps:
  1. Australia: report advertising or other non-compliance to the TGA online [source: TGA notice].
  2. US: device problems go to the FDA; deceptive health or earnings claims go to the FTC [source: FTC blog 2020; FDA MedWatch route uncertain: not verified].
  3. UK, EU, Canada: report to the national device regulator (e.g. MHRA, Health Canada) and the advertising standards body [uncertain: not verified].
  4. Professional misconduct: if a regulated professional is selling the device to patients or making disease claims, follow the profession's informal-then-formal route [source: APA 1.05].
  5. Safeguarding: for children deprived of needed medical care, or exploited vulnerable adults, follow local child and adult safeguarding procedures. Disclose confidential information only as law and policy allow [source: APA 4.05].
• Example language (illustrative): "If you think the claims you were sold on were misleading, there's a regulator you can report that to. Would you like to look at that together?"
• Watch for: the client fearing backlash from their team; your own duty to act where a child is at risk. It is working when the concern is reported or a reasoned decision not to report is documented.

4.10 Documentation and review

• Purpose / when: Throughout.
• Steps:
  1. Record disclosures (4.1), the decisions and their reasons (4.4), consents and coordination (4.5), risk assessments (4.6) and any reports (4.9).
  2. Use neutral wording, for example "client uses a wearable microcurrent device marketed as Healy for sleep".
  3. Set a review date. Steps are [synthesis].
• Example language (illustrative): "I'll note that you're using it for sleep and that your GP knows. Is that accurate?"
• Watch for: pejorative wording in notes. It is working when the record would read fairly to the client.

5. Handling problems

The sources do not address the therapist's role; all guidance in this section is [synthesis] unless a source is cited.

• The client feels judged and stops disclosing. Name the rupture and repair it: "I may have come across as dismissing something that matters to you. That wasn't my intent." Go back to meaning (4.2) and make clear the client's choice stands.
• The client asks you to endorse the device, or to say it is useless. Decline both. Offer to separate the cleared use, the company's concepts and sellers' claims (4.3), and return the evaluation to the client's own observations.
• The client is convinced, and the claims reinforce distrust of medicine. Avoid debating. Explore past experiences with healthcare that fed the distrust, and look for one trusted clinician. Keep coordination (4.5) client-led.
• The device is replacing treatment for depression, anxiety or sleep. Assess severity and risk. Offer evidence-based treatment, and frame it as alongside rather than instead, so the client does not have to give up the device to accept help. Australia's regulator has treated advertising the device for depression, anxiety and related sleep disturbance as outside its approved purpose [source: TGA notice].
• The client stops prescribed medication on a seller's advice. Do not advise on the medicine. Urge prompt contact with the prescriber, offer to help arrange it with consent, and assess risk, including relapse and withdrawal. Document.
• Pressure from the upline or team when the client wants to leave. Treat it as a group-pressure and loss problem. Map relationships, plan conversations, and prepare for loss of community and identity. Use high-control-group indicators if the pressure is intense (cross-reference Domain XII commerce and group dynamics).
• The client is selling to other clients in your waiting room or online group. Set a clear boundary in line with your service policy. Address it privately and without shaming [APA 3.05].
• Family conflict: one partner is buying devices and the other objects, or parents disagree about using it on a child. Hold a joint session if appropriate. Focus on shared values (safety, money, the child's welfare). Safeguarding takes priority over neutrality where a child is deprived of care.
• Regret or shame after spending heavily or recruiting friends. Normalise how persuasive the marketing is. Work through the regret without self-blame, and plan practical repair (budgeting, apologies, possible refund routes). Offer reporting as an option (4.9).
• Non-adherence to agreed coordination, such as the client not telling their GP. Explore barriers such as fear of ridicule. Offer a written note or a joint call, and accept a documented refusal.
• Health anxiety worsens with device "readings". Return to the cycle formulation (4.8) and treat checking as a safety behaviour. Coordinate with the doctor to limit repeated testing.
• The therapist's own reactions (irritation, rescue, or curiosity about buying one). Take it to supervision, keep to your competence and evidence base, and never become a customer or seller through a client [APA 2.01, 2.04, 3.06].

Sources

Web sources:

• FDA 510(k) K191075, Healy (TimeWaver Production GmbH), via Innolitics
• AccessGUDID: DEVICE: Healy (04251784906033)
• TGA: Healy World Australia Pty Ltd, infringement notices ($26,640) for advertising a TENS device
• TGA: Healy World Australia Pty Ltd, Analgesic TENS system, cancelled under s41GL(d)
• Healy app listing (developer Healy World GmbH), MWM
• Jarry J., "The Healy Is Old Woo in New Clothes", McGill Office for Science and Society
• Rolling Stone: "Influencers Are Claiming a $4,000 Hunk of Plastic Can Treat Infertility, Skinned Knees, and Autism"
• BehindMLM: Healy World review (2019, updated)
• BehindMLM: Is Healy World's device FDA approved? (2020, updated 2023)
• FTC Business Blog: FTC again warns multi-level marketers about unproven health and earnings claims (5 June 2020)
• NCCIH: Tips to start talking with your health care providers about complementary health approaches
• APA: Ethical Principles of Psychologists and Code of Conduct

Books cited (as named by the company and sources above) [uncertain: not verified]:

• Becker, R. O. (1985). The Body Electric [uncertain: bibliographic details not verified].