OW100S
FDA 510(k) K233937 · Softwave/Trt, LLC
510(k) numberK233937
Submission
- Device name
- OW100S
- Applicant
- Softwave/Trt, LLC
Woodstock, GA, US - Received
- December 14, 2023
- Decision date
- July 9, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PZL – Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4685
- Specialty
- General, Plastic Surgery
Treatment of diabetic foot ulcers
Other 510(k)s with product code PZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243279 | DOLORCLAST Focused Shock WavesPZL · Traditional | E.M.S Electro Medical Systems S.A | 08/13/2025SE |
| K250779 | CS-Pro MEDPZL · Traditional | Curative Sound Therapeutics | 07/02/2025SE |
| K231710 | OW100SPZL · Traditional | Softwave/Trt, LLC | 09/01/2023SE |
| K202112 | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia HandpiecePZL · Traditional | Storz Medical AG | 02/21/2021SE |
| K200926 | OrthoGold 100PZL · Traditional | Tissue Regeneration Technologies, LLC | 08/28/2020SE |
| K191961 | OrthoGoldPZL · Traditional | Tissue Regeneration Technologies | 11/26/2019SE |
More from Tissue Regeneration Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K231710 | OW100SPZL · Traditional | 09/01/2023SE |
Questions and answers
When was OW100S cleared by the FDA?
OW100S (K233937) received a 510(k) decision of Substantially Equivalent on July 9, 2024, 208 days after the submission was received.
What is the product code of K233937?
The FDA product code is PZL – Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers, a Class II (moderate risk) device regulated under 21 CFR 878.4685.