Device class
Class II
Regulation 876.5960
Total clearances
3
2020-11-25 → 2021-11-24
Definition
What is Computerized Behavioral Therapy Device For Treating Symptoms
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.
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.5960
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Mahana Therapeutics, Inc. |
2 |
0 |
2021-06-02 |
|
Metame Health, Inc. |
1 |
0 |
2021-11-24 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 97163 |
CPT
|
— |
Medium
|
Occupational therapy evaluation - high complexity |
| 90834 |
CPT
|
— |
Low
|
Psychotherapy, 45 minutes |
| 99458 |
CPT
|
— |
Low
|
Remote monitoring of physiologic parameters; interpretation and management services |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2021-11-24 |
K211463 |
Metame Health, Inc.
|
Regulora |
| 2021-06-02 |
K211372 |
Mahana Therapeutics, Inc.
|
Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) |
| 2020-11-25 |
DEN200029 |
Mahana Therapeutics, Inc.
|
Parallel |