Catalog Number

-

Brand Name

Powered Muscle Stimulator

Version/Model Number

KTR-230B

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

K181728

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

14fc731b-2236-47c8-a102-5384685c7bc1

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

January 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-