Identity
- Trade Name
- Winner EVO Combo FDA UDI
- Generic Name
- Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
- Device Name
- Winner CM2P-portable 2 channel combo in a hard carry case FDA UDI
- Model / Reference
- 400-079 FDA UDI
- Description
- Winner CM2P-portable 2 channel combo in a hard carry case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853904006193 FDA UDI
- 510(k) Number
- K013771 FDA UDI
- FDA Product Code
- LIH FDA UDIGZJ FDA UDIIMG FDA UDIIPF FDA UDIIMI FDA UDI
- GMDN Term
- Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI890.5860 FDA UDI890.5850 FDA UDI890.5300 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
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
Yes
FDA UDI
Category: Physical therapy ultrasound/neuromuscular stimulation system
Winner EVO Combo by Compass Health Brands Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Physical therapy ultrasound/neuromuscular stimulation system.
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Cleared under the same submission
K013771 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
- Compass Health Brands Corp.
Sources (1)
- FDA UDI 0811f36f-cb56-4174-9503-e461633d7a1e 35 fields · synced May 30, 2026