Catalog Number

-

Brand Name

Core

Version/Model Number

HD-5N-F

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 02, 2021

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K163393

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

77d31551-40f4-4a1e-bb05-cda9226f9ff2

Public Version Date

November 03, 2021

Public Version Number

7

DI Record Publish Date

November 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-