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Computerized Behavioral Therapy Device For Treating Symptoms

FDA product code QMY · 2 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5960
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2021-06-02 – 2021-11-24

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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