Catalog Number

6302

Brand Name

Revitive ProHealth

Version/Model Number

5572AQ

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

K152480,K190924,K192887,K152480,K190924,K192887

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

3ca6d3c8-c122-469f-9370-2378dd0c4615

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

January 21, 2021

Package DI Number

10858058005259

Quantity per Package

7

Contains DI Package

00858058005252

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer carton