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Repair Windows errors before they cause bigger problemsFix Now →Fix the driver behind crashes, sound loss and screen glitchesFind Drivers →Clear out junk files and repair common Windows errorsFree Scan →DeepWell DTx did not receive FDA clearance for video games generally. On August 1, 2024, the FDA cleared the company’s A Breathing System (ABS), a Class II biofeedback device and software development kit intended to guide and monitor breathing. The cleared indications are stress reduction and adjunctive treatment for high blood pressure—not depression, PTSD, anxiety disorders, or mental illness broadly.
What the FDA cleared
The FDA’s record identifies the product as A Breathing System (ABS), submitted by DeepWell DTx Inc. under the traditional 510(k) pathway. Its 510(k) number is K233580.
- Decision date: August 1, 2024
- Classification: Class II biofeedback device
- Regulation: 21 CFR 882.5050
- Product code: HCC
- FDA panel: Neurology
- Prescription status: Over the counter
- Predicate device: RESPeRATE, K020399
The FDA concluded that ABS was substantially equivalent to the legally marketed predicate. That is why “FDA-cleared through the 510(k) process” is more precise than “FDA-approved.” A 510(k) clearance is not a blanket endorsement of every future product, feature, or marketing claim using the technology.
See the FDA’s clearance decision and indications-for-use document for the regulatory details.
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Was a video game itself FDA-cleared?
No evidence in the FDA record supports that interpretation. The cleared device is ABS, an SDK intended for Android applications. The FDA document does not name Zengence or another commercial game as the cleared product.
DeepWell says developers can incorporate its breathing technology into games and other interactive media. But a finished game would still need to be assessed according to its own intended use, claims, software implementation, labeling, testing, and other applicable requirements. Adding a cleared component does not automatically make the entire game an FDA-cleared medical device.
What ABS does
According to the FDA summary, ABS guides users through breathing exercises and monitors their breathing. It can use an Android device’s integrated microphone to detect breathing rate, with an accelerometer available as an option. The software synchronizes the guidance with the user’s breathing and includes a recovery mechanism if synchronization is lost.
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The FDA summary describes support for Android 6.0 Marshmallow or newer. It was designed around approximately 15-minute sessions and at least 45 minutes of use per week for best results. Those technical details should not be generalized to iOS, consoles, PC, or VR implementations without separate platform documentation.
What conditions are covered?
The cleared indications are narrow:
- Relaxation treatment to reduce stress through interactively guided and monitored breathing exercises.
- Adjunctive treatment for high blood pressure, used alongside pharmacological or non-pharmacological interventions.
This does not establish FDA clearance to treat major depressive disorder, PTSD, generalized anxiety disorder, OCD, bipolar disorder, psychosis, ADHD, loneliness, suicidality, or mental illness generally. The hypertension indication is also adjunctive; it is not authorization to replace medication, monitoring, or clinical care.
Why the clearance matters for games
The significance is the possibility of combining regulated biofeedback with interactive entertainment. DeepWell describes its broader strategy as “immersive medicine,” in which users engage with therapeutic experiences through formats that resemble games.
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Those categories are related but not interchangeable:
- Gamification adds game mechanics to a health intervention.
- A therapeutic game is designed and clinically evaluated for a medical purpose.
- A game containing a cleared medical component may use regulated biofeedback within a larger entertainment experience.
- A wellness game may promote relaxation or well-being without making a medical-treatment claim.
A game mechanic that encourages slow breathing is not automatically validated biofeedback. The regulatory status depends on what the product is intended to do, how it works, and what its developer claims.
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Where Zengence fits
DeepWell presents Zengence as a mental-wellness action shooter built around breathing, movement, precision, rhythm, and stress-management concepts. The company lists it for Meta Quest 2 and Meta Quest 3 on its official website and describes its mechanics on The Lab.
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Zengence is an example of DeepWell’s therapeutic-game approach, but the cited FDA record clears ABS—not necessarily Zengence as a standalone FDA-cleared device. Consumers should not assume that using the game constitutes FDA-cleared treatment for a psychiatric diagnosis.
What the clearance does—and does not—prove
The clearance supports the regulatory status of ABS for its stated breathing, stress, and adjunctive blood-pressure indications. It does not prove that playing games broadly treats mental illness or that every claim made about interactive media has been clinically established.
DeepWell’s public materials discuss mechanisms and possible future applications involving areas such as PTSD, pain, epilepsy, sleep disorders, Parkinson’s disease, and Alzheimer’s disease. The company’s announcement makes clear that those broader indications were not yet cleared. Claims involving vagal activity, dopamine, resilience, or other biological effects should therefore be treated as company claims or hypotheses unless supported by product-specific, peer-reviewed evidence.
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The FDA summary alone does not answer every effectiveness question a consumer or clinician may have: whether the submission relied on new clinical trials, equivalence testing, usability work, or a combination; which outcomes were measured; whether game-specific benefits were tested; whether participants represented people with diagnosed conditions; or how long any benefits lasted after use stopped.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What consumers should know
ABS is classified for over-the-counter use, but that does not mean it is suitable for every person or situation. Stress reduction is not the same as diagnosis or treatment of a psychiatric disorder.
- Do not use a game or breathing tool as a substitute for crisis care, psychotherapy, medication management, or other professional treatment.
- Do not stop blood-pressure medication or monitoring because a product includes breathing biofeedback.
- People with respiratory, cardiovascular, neurological, or psychiatric conditions may want medical advice before relying on a biofeedback product.
- Microphone sensing can be affected by background noise, speech, device placement, or inconsistent breathing.
- Accelerometer-based sensing can be affected by movement, sensor quality, and device compatibility.
- VR adds ordinary headset risks, including motion sickness, visual discomfort, falls, and unsafe play areas.
What it means for developers and investors
For developers, the attraction is a potential way to add breathing biofeedback to mobile software, games, and other interactive experiences. DeepWell’s commercial model is partner-oriented: its site directs prospective partners to contact the company rather than offering a public self-serve SDK price.
Developers still face substantial work after integration, including intended-use analysis, software and platform testing, labeling, cybersecurity, data handling, quality controls, and post-market obligations. “Interactive media” is a commercial description, not a single FDA device category.
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For investors and health-tech companies, the business opportunity depends on more than obtaining a 510(k) clearance. Adoption, clinical validation, user retention, privacy, distribution, clinician acceptance, and reimbursement all matter. DeepWell’s 2024 announcement connected the opportunity with proposed CMS reimbursement codes, but a proposed or potential reimbursement pathway is not guaranteed coverage, payment, or widespread adoption.
The bottom line
DeepWell achieved a meaningful regulatory milestone, but the headline needs narrowing. The FDA cleared A Breathing System, a breathing-and-biofeedback SDK, for stress reduction and adjunctive high-blood-pressure treatment. The clearance creates a possible foundation for therapeutic games and other interactive media; it does not clear video games as a category or authorize treatment for mental-health conditions generally.
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