Device class
Class II
Regulation 878.4685
Total clearances
6
2020-08-28 → 2025-08-13
Definition
What is Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Treatment of diabetic foot ulcers
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4685
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Softwave/Trt, LLC |
2 |
0 |
2024-07-09 |
|
Curative Sound Therapeutics |
1 |
0 |
2025-07-02 |
|
Tissue Regeneration Technologies, LLC |
1 |
0 |
2020-08-28 |
|
E.M.S Electro Medical Systems S.A
|
1 |
0 |
2025-08-13 |
|
Storz Medical AG
|
1 |
0 |
2021-02-21 |
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 |
| 28890 |
CPT
|
— |
Medium
|
CPT for extracorporeal shock wave therapy, lower extremity |
| 97610 |
CPT
|
— |
Medium
|
CPT for low frequency, non-contact normothermic wound therapy |
Pulse
Most recent 510(k) clearances