Catalog Number

TENS3900V2-MFR

Brand Name

Precision TENS3900

Version/Model Number

TENS3900V2-MFR

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

K003487,K003487,K003487

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

c15c6727-c3b0-42ad-9512-adeef849c6b4

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

November 21, 2019

Package DI Number

10850209007013

Quantity per Package

32

Contains DI Package

00850209007023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE