COMPEX - COMPEX TENS/ HEAT CONTROL UNIT FOR BRACING - DJO, LLC

Duns Number:081840873

Device Description: COMPEX TENS/ HEAT CONTROL UNIT FOR BRACING

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More Product Details

Catalog Number

-

Brand Name

COMPEX

Version/Model Number

CX172WI05

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IRT

Product Code Name

PAD, HEATING, POWERED

Device Record Status

Public Device Record Key

7713fe7a-925c-458b-9dd7-ce8eb7aaead7

Public Version Date

August 16, 2022

Public Version Number

2

DI Record Publish Date

June 06, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DJO, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 784
2 A medical device with a moderate to high risk that requires special controls. 1030
3 A medical device with high risk that requires premarket approval 8