Identity
- Trade Name
- TensCare FDA UDI
- Generic Name
- Electromechanical orthopaedic extracorporeal shock wave therapy system FDA UDI
- Device Name
- Shockwave is a solenoid drive activates a bullet body inside the therapeutic handle. When the bullet body collides with the therapeutic head, the impact energy is converted into a radial ballistic shock wave pulse, which is focussed to create the characteristics required to have a good therapeutic effect for musculoskeletal disorders. The innovative technology has a compact design with no need for a compressor. The clear colour display shows all relevant treatment parameters and offers touch screen operation for ease of use during treatment. Variable frequencies and various applicator heads allow treatment to be adapted to the particular condition of the patient. FDA UDI
- Model / Reference
- Shockwave FDA UDI
- Description
- Shockwave is a solenoid drive activates a bullet body inside the therapeutic handle. When the bullet body collides with the therapeutic head, the impact energy is converted into a radial ballistic shock wave pulse, which is focussed to create the characteristics required to have a good therapeutic effect for musculoskeletal disorders. The innovative technology has a compact design with no need for a compressor. The clear colour display shows all relevant treatment parameters and offers touch screen operation for ease of use during treatment. Variable frequencies and various applicator heads allow treatment to be adapted to the particular condition of the patient. FDA UDI
Identifiers
- Catalog Number
- K-SHOCKWAVE FDA UDI
- Primary DI / UDI-DI
- 05033435133796 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
Yes
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
No
FDA UDI
Category: Electromechanical orthopaedic extracorporeal shock wave therapy system
TensCare by Tenscare Limited — 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
- Tenscare Limited
Sources (1)
- FDA UDI 629f44b1-d988-477c-8a7e-9d517bd88817 34 fields · synced Jun 1, 2026