CATALYSY

Wheelchair, Mechanical

KI MOBILITY LLC

The following data is part of a premarket notification filed by Ki Mobility Llc with the FDA for Catalysy.

Pre-market Notification Details

Device IDK062660
510k NumberK062660
Device Name:CATALYSY
ClassificationWheelchair, Mechanical
Applicant KI MOBILITY LLC 4925 COYE DRIVE SUITE D Stevens Point,  WI  54481
ContactDouglas Munsey
CorrespondentSilvia Ankova
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeIOR  
CFR Regulation Number890.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-09-07
Decision Date2006-10-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850013379132 K062660 000
00850013379309 K062660 000
00850013379316 K062660 000
00850013379293 K062660 000
00850013379262 K062660 000
00850013379019 K062660 000
00850013379026 K062660 000
00850013379033 K062660 000
00850013379040 K062660 000
00850013379057 K062660 000
00850013379064 K062660 000
00850013379071 K062660 000
00850013379088 K062660 000
00850013379095 K062660 000
00850013379101 K062660 000
00850013379118 K062660 000
00850013379125 K062660 000
00850013379323 K062660 000

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