Catalog Number

EIPW2

Brand Name

Quickie® Rear Wheel Drive Power Wheelchair

Version/Model Number

EIPW2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 03, 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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K981462

Product Code

ITI

Product Code Name

Wheelchair, powered

Public Device Record Key

5ce9c05c-827d-4f69-b6f0-a62daf7f6fc5

Public Version Date

November 30, 2021

Public Version Number

4

DI Record Publish Date

August 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-