510(k) K211463
K211463 is an FDA 510(k) premarket notification submitted by Metame Health, Inc. for the device "Regulora". The FDA issued a decision of Substantially Equivalent on November 24, 2021. The device falls under product code QMY (Computerized Behavioral Therapy Device For Treating Symptoms), a Class II device regulated under 21 CFR 876.5960.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 2021
- Date Received
- May 11, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computerized Behavioral Therapy Device For Treating Symptoms
- Device Class
- Class II
- Regulation Number
- 876.5960
- Review Panel
- GU
- Submission Type
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.