Catalog Number

2452

Brand Name

Revitive Essential

Version/Model Number

RLV

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

bf0f6f85-c970-4b69-82d6-b6762fc9c930

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

10858058005105

Quantity per Package

6

Contains DI Package

00858058005108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer carton