QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES

Wheelchair, Mechanical

SUNRISE MEDICAL, INC.

The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Quickie Zippie Series, Quickie Breezy Series, Quick Folding Series, Quickie Rigid Series.

Pre-market Notification Details

Device IDK973673
510k NumberK973673
Device Name:QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES
ClassificationWheelchair, Mechanical
Applicant SUNRISE MEDICAL, INC. 7477 EAST DRY CREEK PKWY. Longmont,  CO  80503
ContactRebecca Andersen
CorrespondentRebecca Andersen
SUNRISE MEDICAL, INC. 7477 EAST DRY CREEK PKWY. Longmont,  CO  80503
Product CodeIOR  
CFR Regulation Number890.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-26
Decision Date1997-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05022408045938 K973673 000
00016958045932 K973673 000
00016958043891 K973673 000
00016958056006 K973673 000
00016958099140 K973673 000
00016958047349 K973673 000
00016958057034 K973673 000

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