Catalog Number

-

Brand Name

SHENZHEN JINGKEHUI ELECTRONIC

Version/Model Number

PL-009

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"

Yes

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

-

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

c21f4f87-9eae-4a9d-8396-7e4a9a206ecf

Public Version Date

August 20, 2020

Public Version Number

5

DI Record Publish Date

March 09, 2017

Package DI Number

10867587000307

Quantity per Package

20

Contains DI Package

00867587000300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton