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) and for the acoustic compression therapy (ACT), U: 100-127/220-240VAC, 50/60Hz, Dim. (wxhxd): 405x226x450mm FDA UDI
- Model / Reference
- 100505 FDA UDI
- Description
- PIEZOWAVE 2 CONTROL UNIT for all standard indications in orthopedic extracorporeal shockwave therapy (ESWT) and trigger point shockwave therapy (TPST) and for the acoustic compression therapy (ACT), U: 100-127/220-240VAC, 50/60Hz, Dim. (wxhxd): 405x226x450mm FDA UDI
Identifiers
- Catalog Number
- 100505 FDA UDI
- Primary DI / UDI-DI
- 04055207008454 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 717737fb-b730-45e7-bdd5-cbcfd224be64 35 fields · synced Jun 8, 2026