Device class
Class II
Regulation 890.5290
Total clearances
4
2023-05-24 → 2026-06-12
Classification details
Medical specialty
Physical Medicine
Regulation number
890.5290
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Regenesis Biomedical, Inc. |
1 |
0 |
2023-05-24 |
|
Enraf-Nonius, B.V.
|
1 |
0 |
2025-06-25 |
|
BTL Industries, Inc.
|
1 |
1 |
2026-06-12 |
|
Viatherm Therapeutics, LLC |
1 |
1 |
2025-11-05 |
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 |
| 97024 |
CPT
|
— |
High
|
CPT for therapeutic procedure with shortwave diathermy for deep heat |
| E0891 |
HCPCS
|
— |
Medium
|
HCPCS for shortwave diathermy equipment |
Pulse
Most recent 510(k) clearances