Computerized Behavioral Therapy Device For Treating Symptoms

QMY · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5960

Classification

FDA Product Code: QMY
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.5960
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown