Catalog Number

-

Brand Name

1BYONE

Version/Model Number

725EU-0002

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K153520,K153520,K153520

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

8ad3bc40-ac4d-4dac-b406-67e31dd15a6c

Public Version Date

March 14, 2022

Public Version Number

5

DI Record Publish Date

May 24, 2017

Package DI Number

10858069007020

Quantity per Package

200

Contains DI Package

00858069007023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer carton