Catalog Number

-

Brand Name

Pulse Massager

Version/Model Number

MP-TENS310-US

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131921,K131921,K131921

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

4764d727-3b7f-4e1f-b0c6-328de18eed4b

Public Version Date

July 23, 2020

Public Version Number

4

DI Record Publish Date

November 18, 2016

Package DI Number

00817746020403

Quantity per Package

1

Contains DI Package

00817746020397

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-