AXUS ES-5 - The AXUS ES-5 is an electro-acupuncture device - TENS PLUS INDUSTRIAL COMPANY

Duns Number:663211978

Device Description: The AXUS ES-5 is an electro-acupuncture device indicated for use in the practice of acupun

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

ED3930

Brand Name

AXUS ES-5

Version/Model Number

ED3930

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K200636

Product Code Details

Product Code

BWK

Product Code Name

Stimulator, Electro-Acupuncture

Device Record Status

Public Device Record Key

6c53cf5a-700d-4d1e-a4b0-096d8d8d5da2

Public Version Date

April 07, 2021

Public Version Number

1

DI Record Publish Date

March 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TENS PLUS INDUSTRIAL COMPANY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1
U Unclassified 1