Catalog Number

-

Brand Name

PURE ENRICHMENT

Version/Model Number

PEPULSEDUO

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141299,K141299

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

eb0e3fe7-30ac-4b80-975d-893ffb7bfdf9

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

February 11, 2017

Package DI Number

B311PEPULSEDUO1

Quantity per Package

32

Contains DI Package

B311PEPULSEDUO0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX