K233937
- 510(k) number
- K233937
- Device name
- OW100S
- Applicant
- Softwave/Trt, LLC GA · US
- Product code
- PZL — Extracorporeal Shock Wave Device For Treatment Of Di
- Decision date
- 2024-07-09
- Date received
- 2023-12-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K233937.pdf
Official FDA record: K233937
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.