BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair

Wheelchair, Powered

21st Century Scientific, Inc.

The following data is part of a premarket notification filed by 21st Century Scientific, Inc. with the FDA for Bounder 300 Power Wheelchair, Bounder Plus 300 Power Wheelchair, Bounder 450 Power Wheelchair, Big Bounder 600 Power Wheelchair, Big Bounder 1000 Power Wheelchair.

Pre-market Notification Details

Device IDK193599
510k NumberK193599
Device Name:BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair
ClassificationWheelchair, Powered
Applicant 21st Century Scientific, Inc. 4931 N Manufacturing Way Coeur D'alene,  ID  83815
ContactRd Davidson
CorrespondentRd Davidson
21st Century Scientific, Inc. 4931 N Manufacturing Way Coeur D'alene,  ID  83815
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-09-03

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