Catalog Number

ET-5050

Brand Name

iReliev

Version/Model Number

ET-5050

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"

Yes

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

d51f7372-d7f5-4f89-9abb-ac62305048b0

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

January 12, 2018

Package DI Number

00853635002433

Quantity per Package

20

Contains DI Package

00853635002426

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton