Catalog Number

KB0918423-PAD230

Brand Name

BioKnit Back Brace 7" Conductive Garment - Kit

Version/Model Number

KB0918423

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K053214

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

2e2350ee-a5d7-42d5-bf1f-604358e7d3e8

Public Version Date

August 03, 2022

Public Version Number

1

DI Record Publish Date

July 26, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-