Neurotech Kneehab - KNEEHAB PLUS GARMENT EXTENDER KIT - THERAGEN, LLC

Duns Number:080028759

Device Description: KNEEHAB PLUS GARMENT EXTENDER KIT

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More Product Details

Catalog Number

-

Brand Name

Neurotech Kneehab

Version/Model Number

0411-5038

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Device Record Status

Public Device Record Key

56851535-241d-4e5f-9bd6-bd51d4af92d5

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

December 05, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THERAGEN, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 15
3 A medical device with high risk that requires premarket approval 11