AccessGUDID - DEVICE: Winner EVO Combo (00853904006193)

GUDID

Device Identifier (DI) Information

Brand Name: Winner EVO Combo
Version or Model: 400-079
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COMPASS HEALTH BRANDS CORP.

Primary DI Number: 00853904006193
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827221698 *Terms of Use

Device Description: Winner CM2P-portable 2 channel combo in a hard carry case

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17908	Physical therapy ultrasound/neuromuscular stimulation system	An assembly of devices that includes a neuromuscular electrical stimulator as an integral part of a therapeutic ultrasound system intended for the simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and to help reduce muscle spasms and pain; it may in addition be capable of delivering either energy alone. The system is designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIH	Interferential Current Therapy
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief
IMG	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
IPF	Stimulator, Muscle, Powered
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013771	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0811f36f-cb56-4174-9503-e461633d7a1e
Public Version Date: August 21, 2023
Public Version Number: 3
DI Record Publish Date: November 21, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-376-7263
Email: customerservice@compasshealthbrands.com

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