Computerized Behavioral Therapy Device For Treating Symptoms
The Computerized Behavioral Therapy Device for Treating Symptoms is a prescription digital therapeutic device intended to provide a computerized version of condition-specific behavioral therapy as an adjunct to standard of care treatments for patients with gastrointestinal conditions such as irritable bowel syndrome. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 876.5960 in the Gastroenterology and Urology specialty. It carries product code QMY and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QMY
- Device Class
- FDA class 2
- Regulation Number
- 876.5960
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K211463 | Regulora | Nov 24, 2021 | Substantially Equivalent | Metame Health, Inc. |
| K211372 | Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) | Jun 02, 2021 | Substantially Equivalent | Mahana Therapeutics, Inc. |
| DEN200029 | Parallel | Nov 25, 2020 | Unknown | Mahana Therapeutics, Inc. |