Catalog Number

-

Brand Name

Bio Protech

Version/Model Number

MaxTens 1k

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

1e3414e8-a885-4875-a2ab-e9df36fdf842

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

June 15, 2016

Package DI Number

00817120020029

Quantity per Package

8

Contains DI Package

00817120020012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case