QMY — Computerized Behavioral Therapy Device For Treating Symptoms Class II
FDA product code QMY covers "Computerized Behavioral Therapy Device For Treating Symptoms", a Class II medical device regulated under 21 CFR 876.5960. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QMY
- Device Class
- Class II
- Regulation Number
- 876.5960
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.