Catalog Number

-

Brand Name

Bio Protech

Version/Model Number

MaxTens 2k

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

Yes

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

75478872-04ac-4a83-b8c4-162ddb08645b

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

June 16, 2016

Package DI Number

10817120020033

Quantity per Package

5

Contains DI Package

00817120020036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box