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Winner EVO Combo

FDA UDI

Class II (US FDA UDI)

by Compass Health Brands Corp.

Identity

Trade Name
Winner EVO Combo FDA UDI
Generic Name
Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
Device Name
Winner CM4P-portable 4 channel combo in a hard carry case FDA UDI
Model / Reference
400-006 FDA UDI
Description
Winner CM4P-portable 4 channel combo in a hard carry case FDA UDI

Identifiers

Primary DI / UDI-DI
00853904006209 FDA UDI
FDA Product Code
LIH FDA UDI
GZJ FDA UDI
IPF FDA UDI
GMDN Term
Physical therapy ultrasound/neuromuscular stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
890.5850 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

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

Similar devices

Also classified as Physical therapy ultrasound/neuromuscular stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Compass Health Brands Corp.

Sources (1)

  • FDA UDI 793b913e-6dd1-49d8-9dea-7576948b360f 34 fields · synced May 30, 2026