Identity
- Trade Name
- Profile Applicator FDA UDI
- Generic Name
- Dermatological extracorporeal shock wave therapy system applicator FDA UDI
- Device Name
- Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100) FDA UDI
- Model / Reference
- FLE0103 FDA UDI
- Description
- Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812265010294 FDA UDI
- FDA Product Code
- ISA FDA UDI
- GMDN Term
- Dermatological extracorporeal shock wave therapy system applicator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatological extracorporeal shock wave therapy system applicator
Profile Applicator by SANUWAVE Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological extracorporeal shock wave therapy system applicator.
- dermaPACE Applicator — SANUWAVE Health, Inc. · Class II
- Profile Applicator — SANUWAVE Health, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SANUWAVE Health, Inc.
Sources (1)
- FDA UDI c0d43bcc-b3cd-43fc-be1c-3db053d60cb8 34 fields · synced Jun 6, 2026