Catalog Number

-

Brand Name

Vive

Version/Model Number

RHB1041

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

K121719,K121719

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

b955cc58-0732-4626-9fe5-1c824b1ee10e

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

December 12, 2017

Package DI Number

10818323021773

Quantity per Package

100

Contains DI Package

00818323021776

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case