Identity
- Trade Name
- Swiss DolorClast FDA UDI
- Generic Name
- Pneumatic orthopaedic extracorporeal shock wave therapy system FDA UDI
- Device Name
- Handpiece kit DolorClast FDA UDI
- Model / Reference
- FR-137 FDA UDI
- Description
- Handpiece kit DolorClast FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07613353000028 FDA UDI
- PMA Number
- P050004 FDA UDI
- FDA Product Code
- NBN FDA UDI
- GMDN Term
- Pneumatic orthopaedic extracorporeal shock wave therapy system FDA UDI
Classification
- Device Class
- Class III 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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
Swiss DolorClast by E.M.S. Electro Medical Systems S.A. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CHATTANOOGA — DJO, LLC · Class I
- CHATTANOOGA — DJO, LLC · Class II
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Cleared under the same submission
P050004 also covers:
- SWISS DOLORCLAST — E.M.S. Electro Medical Systems S.A.
- Swiss DolorClast — E.M.S. Electro Medical Systems S.A.
- Swiss DolorClast — E.M.S. Electro Medical Systems S.A.
- Swiss DolorClast — E.M.S. Electro Medical Systems S.A.
- Swiss DolorClast — E.M.S. Electro Medical Systems S.A.
- Swiss DolorClast — E.M.S. Electro Medical Systems S.A.
- Swiss DolorClast — E.M.S. Electro Medical Systems S.A.
- Swiss DolorClast — E.M.S. Electro Medical Systems S.A.
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- E.M.S. Electro Medical Systems S.A.
Sources (1)
- FDA UDI 47c33e2b-1a6a-4c18-a390-d0c846c51752 35 fields · synced Jun 8, 2026