Catalog Number

P642000

Brand Name

Pro Advantage

Version/Model Number

P642000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K073438,K073438

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

846e3f5a-817f-4902-8ee1-6fa9106e139f

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

February 13, 2017

Package DI Number

M220P6420003

Quantity per Package

5

Contains DI Package

M220P6420002

Package Discontinue Date

-

Package Status

-

Package Type

Box