Catalog Number

GP208

Brand Name

WHEELCHAIR POWERED

Version/Model Number

GP208

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 2019

Issuing Agency

In HIBCC

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K011153

Product Code

ITI

Product Code Name

Wheelchair, Powered

Public Device Record Key

496c206f-2577-412a-939e-64cd668d7525

Public Version Date

April 30, 2019

Public Version Number

1

DI Record Publish Date

April 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-