Identity
- Trade Name
- OmniVersa FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Combination electrical stimulation/ultrasound for physical therapy FDA UDI
- Model / Reference
- 100FXF FDA UDI
- Description
- Combination electrical stimulation/ultrasound for physical therapy FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858703006139 FDA UDI
- 510(k) Number
- K153559 FDA UDI
- FDA Product Code
- IMG FDA UDIGZJ FDA UDIIPF FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5860 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
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation systemMusculoskeletal intense therapeutic ultrasound system
OmniVersa by Accelerated Care Plus Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K153559 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
- Accelerated Care Plus Corp.
Sources (1)
- FDA UDI ec5f5db5-bec9-4625-a1c8-50c66ccccb24 35 fields · synced Jun 6, 2026