Identity
- Trade Name
- Omnistim FX2 Pro FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- The Omnistim® FX2 Pro Sport provides Patterned Electrical Neuromuscular Stimulation (PENS), which is a form of gentle stimulation that replicates the correct firing patterns of muscles (agonist and antagonist or reciprocal muscle pairs) in triphasic (ballistic), biphasic (reciprocal), or functional patterns. This approach to neuro re-ed provides a high intensity, precisely timed sensory input, which duplicates the firing activity of sensory neurons and muscle stretch receptors during voluntary activity. FDA UDI
- Model / Reference
- 100FX2C FDA UDI
- Description
- The Omnistim® FX2 Pro Sport provides Patterned Electrical Neuromuscular Stimulation (PENS), which is a form of gentle stimulation that replicates the correct firing patterns of muscles (agonist and antagonist or reciprocal muscle pairs) in triphasic (ballistic), biphasic (reciprocal), or functional patterns. This approach to neuro re-ed provides a high intensity, precisely timed sensory input, which duplicates the firing activity of sensory neurons and muscle stretch receptors during voluntary activity. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858703006023 FDA UDI
- FDA Product Code
- IPF FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI
- Commercial Distribution
- Not 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
Omnistim FX2 Pro by Accelerated Care Plus Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Accelerated Care Plus Corp.
Sources (1)
- FDA UDI 67bbd277-0eab-4d60-ae21-8c94a6004009 35 fields · synced May 30, 2026