Catalog Number

5737

Brand Name

Revitive Medic Knee

Version/Model Number

2836AB

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

-

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

K190924,K190924

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

f26aea49-44ad-48f8-ba5e-8abacad5c977

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

10858058005181

Quantity per Package

6

Contains DI Package

00858058005184

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer carton