Catalog Number

7290016633641

Brand Name

TONEm

Version/Model Number

H5003

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

K180279,K180279,K180279

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

5a7780f5-2c92-462e-b66e-cdfd7a4df374

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

July 01, 2020

Package DI Number

27290016633645

Quantity per Package

4

Contains DI Package

17290016633648

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box