Catalog Number

ET-5555

Brand Name

iReliev

Version/Model Number

ET-5555

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

K161453,K161453

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

ad6ee07d-7883-43c8-9acb-bf78e0ced510

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

January 12, 2018

Package DI Number

10853635002447

Quantity per Package

40

Contains DI Package

00853635002440

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton