QMY
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Computerized Behavioral Therapy Device For Treating Symptoms
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5960
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- A computerized behavioral therapy device for treating symptoms of gastrointestinal conditions is a prescription device intended to provide a computerized version of condition-specific therapy as an adjunct to standard of care treatments to patients with gastrointestinal conditions.
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| Record | Firm | Date |
|---|---|---|
| Regulora (K211463) | Metame Health, Inc. | 2021-11-24 |
| Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) (K211372) | Mahana Therapeutics, Inc. | 2021-06-02 |
| Parallel (DEN200029) | Mahana Therapeutics, Inc. | 2020-11-25 |
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