510(k) K233937
- Device
- OW100S
- Applicant
- Softwave/Trt, LLC
- 510(k) number
- K233937
- Product code
- PZL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-09
- Date received
- 2023-12-14
- Regulation
- 878.4685
- Classification name
- Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Cherita James
- Address
- 3330 Hwy. 136 W. Woodstock GA US 30175 30175
FDA Registration Numbers#
- 9613347
- 3043011436
- 3017132875
- 3023808190
- 3008530360
- 1061158
- 3039142471
- 3043012240
- 3043012074
- 3043149902
- 3006066512
- 3042228064
- 8030987
- 3005462245
- 3031233199
- 3031233197
Source Documents#
Other 510(k) Records For Product Code PZL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243279 | DOLORCLAST Focused Shock Waves | E.M.S Electro Medical Systems S.A | 2025-08-13 |
| K250779 | CS-Pro MED | Curative Sound Therapeutics | 2025-07-02 |
| K231710 | OW100S | Softwave/Trt, LLC | 2023-09-01 |
| K202112 | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece | Storz Medical AG | 2021-02-21 |
| K200926 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | 2020-08-28 |
| K191961 | OrthoGold | Tissue Regeneration Technologies | 2019-11-26 |
| DEN160037 | dermaPACE System | Sanuwave, Inc. | 2017-12-28 |