Catalog Number

-

Brand Name

Famidoc

Version/Model Number

FDES107

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

K130723,K130723

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

dd960a17-fedd-498f-9b2b-8496cab1194a

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

December 29, 2016

Package DI Number

10854314007517

Quantity per Package

48

Contains DI Package

00854314007510

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-