Quickie Q700-UP M / Q700M - Power wheelchair, midwheel drive with or without - SUNRISE MEDICAL (US) LLC

Duns Number:962525056

Device Description: Power wheelchair, midwheel drive with or without stand-up feature.

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More Product Details

Catalog Number

EIPW25

Brand Name

Quickie Q700-UP M / Q700M

Version/Model Number

Q700-UP M / Q700M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

K060531,K172384

Product Code Details

Product Code

IPL

Product Code Name

Wheelchair, Standup

Device Record Status

Public Device Record Key

1e028f6b-72f1-4cf4-a560-36c1ba0cd911

Public Version Date

May 11, 2021

Public Version Number

1

DI Record Publish Date

May 03, 2021

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