Identity
- Trade Name
- PIEZOWAVE2 FDA UDI
- Generic Name
- Electromechanical orthopaedic extracorporeal shock wave therapy system FDA UDI
- Device Name
- PIEZOWAVE 2 CONTROL UNIT for all standard indications in orthopedic extracorporeal shockwave therapy (ESWT) and trigger point shockwave therapy (TPST) as well as for acoustic compression therapy, touch screen, color display, control by footswitch, U: 100-240VAC, 50/60Hz, Dim. (wxhxd) 405x226x450mm FDA UDI
- Model / Reference
- 100506 FDA UDI
- Description
- PIEZOWAVE 2 CONTROL UNIT for all standard indications in orthopedic extracorporeal shockwave therapy (ESWT) and trigger point shockwave therapy (TPST) as well as for acoustic compression therapy, touch screen, color display, control by footswitch, U: 100-240VAC, 50/60Hz, Dim. (wxhxd) 405x226x450mm FDA UDI
Identifiers
- Catalog Number
- 100506 FDA UDI
- Primary DI / UDI-DI
- 04055207063989 FDA UDI
- FDA Product Code
- ISA FDA UDI
- GMDN Term
- Electromechanical orthopaedic extracorporeal shock wave therapy system 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: Electromechanical orthopaedic extracorporeal shock wave therapy system
Piezowave2 by Richard Wolf GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Richard Wolf GmbH
Sources (1)
- FDA UDI cc0bd70f-6c99-43ce-ac06-8e495c266c1c 35 fields · synced May 30, 2026