Catalog Number

COM-TENS

Brand Name

Medical Science Products

Version/Model Number

COM-TENS

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K071624,K071624,K071624

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

5b73e5fe-8c99-47d5-8736-50eda0d82bc3

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

May 29, 2018

Package DI Number

00851610008333

Quantity per Package

1

Contains DI Package

00851610008326

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag