Catalog Number

TENS 3MT

Brand Name

Therapist’s Choice® TENS 3MT

Version/Model Number

TENS 3MT

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K073438,K073438,K073438

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

c6248284-cb52-4ec0-89cb-aec9d4a10adf

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

January 29, 2019

Package DI Number

00815290016385

Quantity per Package

8

Contains DI Package

00815290016378

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case