Identity
- Trade Name
- Soleo SonoStim FDA UDI
- Generic Name
- Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
- Model / Reference
- 5340 FDA UDI
Identifiers
- Catalog Number
- 5340 FDA UDI
- Primary DI / UDI-DI
- 04053815003304 FDA UDI
- 510(k) Number
- K121059 FDA UDI
- FDA Product Code
- LIH FDA UDIIPF FDA UDIIMI FDA UDIIMG FDA UDIGZJ FDA UDI
- GMDN Term
- Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI890.5850 FDA UDI890.5300 FDA UDI890.5860 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
No
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: Physical therapy ultrasound/neuromuscular stimulation system
Soleo SonoStim by Zimmer MedizinSysteme GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121059 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zimmer MedizinSysteme GmbH
Sources (1)
- FDA UDI ef9083fd-bd46-42de-bd0b-fc448da525ea 35 fields · synced May 30, 2026