Catalog Number

-

Brand Name

1BYONE

Version/Model Number

725EU-0003

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

c0e96bd7-629f-4c12-88d1-fb2b7243645d

Public Version Date

March 14, 2022

Public Version Number

5

DI Record Publish Date

May 24, 2017

Package DI Number

10863696000399

Quantity per Package

120

Contains DI Package

00863696000392

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer carton