Identity
- Trade Name
- Sonicator Plus 920 FDA UDI
- Generic Name
- Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
- Device Name
- Two-channel combination unit for therapeutic ultrasound and muscle stimulation FDA UDI
- Model / Reference
- ME 920 FDA UDI
- Description
- Two-channel combination unit for therapeutic ultrasound and muscle stimulation FDA UDI
Identifiers
- Catalog Number
- ME 920 FDA UDI
- Primary DI / UDI-DI
- 00816864020210 FDA UDI
- 510(k) Number
- K111482 FDA UDI
- FDA Product Code
- GZI FDA UDIIMG FDA UDIGZJ FDA UDIIPF FDA UDI
- GMDN Term
- Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5810 FDA UDI890.5860 FDA UDI882.5890 FDA UDI890.5850 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
Yes
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
Dimensions & Sizes
- Size
- Weight — 11 Pound FDA UDI
Category: Physical therapy ultrasound/neuromuscular stimulation system
Sonicator Plus 920 by Mettler Electronics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K111482 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 |
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Manufacturer
- Manufacturer
- Mettler Electronics Corp.
Sources (1)
- FDA UDI 4ad0e7a8-b82c-4a54-9b84-775c7d708d44 38 fields · synced May 30, 2026