Catalog Number

-

Brand Name

STIMFIT

Version/Model Number

1.03

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K031611,K031611,K031611,K031611,K031611

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

33586904-3c8e-4361-84ef-894d2c4f1729

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

November 28, 2016

Package DI Number

07640174840021

Quantity per Package

1

Contains DI Package

07640174840007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box