Catalog Number

ES-130

Brand Name

ES-130

Version/Model Number

ES-130

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K081943,K081943,K081943

Product Code

BWK

Product Code Name

Stimulator, Electro-Acupuncture

Public Device Record Key

b5922f5f-39ea-46d8-b3f2-4463222425ad

Public Version Date

December 07, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

14983087008400

Quantity per Package

20

Contains DI Package

04983087008403

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-