Computerized Behavioral Therapy Device For Treating Symptoms
QMY is the FDA product code for Computerized Behavioral Therapy Device For Treating Symptoms, a class II device type, regulated under 21 CFR 876.5960. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QMY
- Device name
- Computerized Behavioral Therapy Device For Treating Symptoms
- 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.
- Regulation
- 21 CFR 876.5960
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 0
Clearances, product code QMY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2021 | 2 |
Applicants with the most clearances
Product code QMY| Applicant | Clearances |
|---|---|
| Mahana Therapeutics, Inc. | 2 |
| Metame Health, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QMY.
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