FDA product code QMY

Computerized Behavioral Therapy Device For Treating Symptoms

Gastroenterology, Urology·Class 2·21 CFR 876.5960
US regulatory classifications
US Product Code (FDA)
QMY
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 876.5960
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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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About this record

Computerized Behavioral Therapy Device For Treating Symptoms is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.