Identity
- Trade Name
- Sonicator Plus 994, 4 channel FDA UDI
- Generic Name
- Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
- Device Name
- Microprocessor-controlled with 4 channel combination unit FDA UDI
- Model / Reference
- ME 994 FDA UDI
- Description
- Microprocessor-controlled with 4 channel combination unit FDA UDI
Identifiers
- Catalog Number
- ME 994 FDA UDI
- Primary DI / UDI-DI
- 00816864020258 FDA UDI
- 510(k) Number
- K984142 FDA UDI
- FDA Product Code
- IPF FDA UDILIH FDA UDIGZJ FDA UDI
- GMDN Term
- Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI882.5890 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 — 10.7 Pound FDA UDI
Category: Physical therapy ultrasound/neuromuscular stimulation system
Sonicator Plus 994, 4 channel 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
K984142 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 b098ba47-3e1e-4cb1-a581-be2ef4dc917b 38 fields · synced Jun 1, 2026