FDA product code QMY: Computerized Behavioral Therapy Device For Treating Symptoms
QMY is the FDA product code for computerized behavioral therapy device for treating symptoms. It is a Class II device, regulated under 21 CFR 876.5960 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under QMY, from 2 different applicants. The average 510(k) review took 113 days (median 113). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Computerized Behavioral Therapy Device For Treating Symptoms |
| Device class | Class II |
| Regulation | 21 CFR 876.5960 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QMY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 2 | 113 |
Compare with all 510(k) review times · Search every QMY clearance
Top QMY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Metame Health, Inc. | 1 | 2021-11-24 |
| Mahana Therapeutics, Inc. | 1 | 2021-06-02 |
Most recent QMY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211463 | Metame Health, Inc. | Regulora | 2021-11-24 | 197 |
| K211372 | Mahana Therapeutics, Inc. | Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) | 2021-06-02 | 29 |
Recalls for QMY devices
openFDA lists no recalls for product code QMY.
Frequently asked questions
What is FDA product code QMY?
QMY is the FDA product code for computerized behavioral therapy device for treating symptoms. It is a Class II device, regulated under 21 CFR 876.5960 and reviewed by the Gastroenterology and Urology panel.
What device class is QMY?
Class II, regulation 21 CFR 876.5960. Typical premarket route: 510(k).
How long does a 510(k) take for product code QMY?
Across 2 cleared submissions the average was 113 days from receipt to decision (median 113).
Which companies have the most QMY clearances?
Metame Health, Inc. (1); Mahana Therapeutics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QMY
- Run a recall and safety report across every QMY manufacturer
- Watch product code QMY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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