Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

AGF-6X

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

K020750,K020750

Product Code

IPF

Product Code Name

Stimulator, muscle, powered

Public Device Record Key

5ed20a5c-3c99-4d02-a2bf-b9e001e8fd3f

Public Version Date

October 18, 2021

Public Version Number

8

DI Record Publish Date

July 01, 2016

Package DI Number

00822383304557

Quantity per Package

30

Contains DI Package

00822383104553

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-