Catalog Number

2616

Brand Name

Revitive Medic

Version/Model Number

2469MD

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,K152480

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

5e74d58f-4e9d-4444-a67f-91547f98b263

Public Version Date

May 23, 2019

Public Version Number

3

DI Record Publish Date

April 23, 2018

Package DI Number

10858058005082

Quantity per Package

6

Contains DI Package

00858058005085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer carton