Catalog Number

-

Brand Name

Pulse Massager

Version/Model Number

MP-TENS510-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

K153520,K153520,K153520

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

956a8628-3c00-415a-90e6-f72c1fef4af9

Public Version Date

July 23, 2020

Public Version Number

5

DI Record Publish Date

May 26, 2017

Package DI Number

00817746020939

Quantity per Package

1

Contains DI Package

00817746020915

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-