Profile Applicator FLE0104
Profile Applicator FLE0104 is a medical device (FDA Class I; FDA product code ISA, Massager, Therapeutic, Electric) made by SANUWAVE Health, Inc., listed in FDA GUDID since 25 Jan 2021 (UDI-DI 00812265010300), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00812265010300 | Date25 Jan 2021 | StatusListed |
Official records
- AccessGUDID record 00812265010300
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Profile Applicator
- Generic name
- Dermatological extracorporeal shock wave therapy system applicator
- Model / reference
- FLE0104
- Primary DI / UDI-DI
- 00812265010300
- FDA product code
- ISA
- GMDN term
- Dermatological extracorporeal shock wave therapy system applicator
- Device class
- Class I
- Regulation number
- 890.5660
- GUDID distribution status
- In Commercial Distribution
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