Catalog Number

-

Brand Name

Jiajian

Version/Model Number

CMNS6-1

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

K130768

Product Code

BWK

Product Code Name

Stimulator, Electro-Acupuncture

Public Device Record Key

38f8a733-57e9-4e62-b919-68c7ffda129e

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

October 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-