← Back to catalogue

Winner Evo CM2 - 120V

FDA UDI

Class II (US FDA UDI)

by Compass Health Brands Corp.

Identity

Trade Name
Winner Evo CM2 - 120V FDA UDI
Generic Name
Physical therapy ultrasound system FDA UDI
Device Name
Winner Evo CM2 Device W/ HAMMER, electrodes, gel and lead wires FDA UDI
Model / Reference
410-010-HMR FDA UDI
Description
Winner Evo CM2 Device W/ HAMMER, electrodes, gel and lead wires FDA UDI

Identifiers

Primary DI / UDI-DI
00092237902523 FDA UDI
510(k) Number
K013771 FDA UDI
FDA Product Code
IMG FDA UDI
IPF FDA UDI
GZJ FDA UDI
LIH FDA UDI
GMDN Term
Physical therapy ultrasound system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5860 FDA UDI
890.5850 FDA UDI
882.5890 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 system

Winner Evo CM2 - 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 system.

Cleared under the same submission

K013771 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Compass Health Brands Corp.

Sources (1)

  • FDA UDI 3b9c1202-721f-4c3f-848d-82b429c3f544 35 fields · synced May 30, 2026