Quickie Q400M/ Q500M Series Power Chair - Quickie Q400/ Q500 mid-wheel drive power - SUNRISE MEDICAL (US) LLC

Duns Number:962525056

Device Description: Quickie Q400/ Q500 mid-wheel drive power wheelchair

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More Product Details

Catalog Number

92282

Brand Name

Quickie Q400M/ Q500M Series Power Chair

Version/Model Number

5871

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 03, 2021

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

ITI

Product Code Name

Wheelchair, powered

Device Record Status

Public Device Record Key

ad0703da-5eb0-469d-ad12-9f54deead40a

Public Version Date

November 30, 2021

Public Version Number

2

DI Record Publish Date

January 05, 2019

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