Catalog Number

-

Brand Name

TheraKnit

Version/Model Number

TKP-1080

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K053214,K053214

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

230b8101-1260-4552-a49d-d1a508a0ab57

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

November 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-