Quickie® Rear Wheel Drive Power Wheelchair - P222 SE Power Wheelchair - SUNRISE MEDICAL (US) LLC

Duns Number:962525056

Device Description: P222 SE Power Wheelchair

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More Product Details

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

Product Characteristics

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 Details

Product Code

ITI

Product Code Name

Wheelchair, powered

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUNRISE MEDICAL (US) LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 18