FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OW100S
K Number: K231710
·
Decision Sep 1, 2023
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
7
Applicant Total
2
Review Days
81
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Basic Information
- Device Name
- OW100S
- K Number
- K231710
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4685
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Softwave/Trt, LLC
- Date Received
- June 12, 2023
- Decision Date
- September 1, 2023
- Product Code
- PZL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PZL | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Softwave/Trt, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K233937 | OW100S | Jul 9, 2024 | Substantially Equivalent |