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CM4 Winner Evo Device - 120V

FDA UDI

Class II (US FDA UDI)

by Compass Health Brands Corp.

Identity

Trade Name
CM4 Winner Evo Device - 120V FDA UDI
Generic Name
Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
Device Name
CM4 Winner Evo Device WITH hammer, electrodes, gel, lead wires & CART FDA UDI
Model / Reference
410-012-PK FDA UDI
Description
CM4 Winner Evo Device WITH hammer, electrodes, gel, lead wires & CART FDA UDI

Identifiers

Primary DI / UDI-DI
00092237902547 FDA UDI
FDA Product Code
IMI FDA UDI
GZJ FDA UDI
IPF FDA UDI
LIH FDA UDI
GMDN Term
Physical therapy ultrasound/neuromuscular stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5300 FDA UDI
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

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

Category: Physical therapy ultrasound/neuromuscular stimulation system

CM4 Winner Evo Device - 120V 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 21feb36b-2bb8-4844-9cdf-7a9478c6cc04 34 fields · synced May 29, 2026