Identity
- Trade Name
- Radial Pressure Pulse Therapy Device FDA UDI
- Generic Name
- Pneumatic orthopaedic extracorporeal shock wave therapy system FDA UDI
- Model / Reference
- PZ-3201P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976927170031 FDA UDI
- FDA Product Code
- ISA FDA UDI
- GMDN Term
- Pneumatic 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: Pneumatic orthopaedic extracorporeal shock wave therapy system
Radial Pressure Pulse Therapy Device by Guangzhou Pinzhi Medical Technology Co., LTD — 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
- Guangzhou Pinzhi Medical Technology Co., LTD
Sources (1)
- FDA UDI 7c0f87eb-2128-404c-ab57-f7dc0cb8b6c4 32 fields · synced Jun 8, 2026