Identity
- Trade Name
- Soleo Sono FDA UDI
- Generic Name
- Physical therapy ultrasound system FDA UDI
- Model / Reference
- 5345 FDA UDI
Identifiers
- Catalog Number
- 5345 FDA UDI
- Primary DI / UDI-DI
- 04053815003311 FDA UDI
- 510(k) Number
- K121059 FDA UDI
- FDA Product Code
- IMI FDA UDI
- GMDN Term
- Physical therapy ultrasound system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5300 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 system
Soleo Sono by Zimmer MedizinSysteme GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Physical therapy ultrasound system.
- CHATTANOOGA — DJO, LLC · Class II
- PainShield MD Supplies Kit — NANOVIBRONIX INC. · Class II
- Sonicator 719 — METTLER ELECTRONICS CORP. · Class II
- Sonopuls 190 — Enraf-Nonius B.V. · Class II
- JAS Pulse 3MHz — AXIOSONIC, LLC · Class II
- TheraTouch UX2 — COMPASS HEALTH BRANDS CORP. · Class II
- AUTOSOUND — COMPASS HEALTH BRANDS CORP. · Class II
- Sonopuls 190 — Enraf-Nonius B.V. · Class II
Cleared under the same submission
K121059 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI e9f19c25-a719-4f4a-b58d-8abc5333db23 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026