RGK Daily Range Wheelchairs

Wheelchair, Mechanical

RGK Wheelchairs, Ltd.

The following data is part of a premarket notification filed by Rgk Wheelchairs, Ltd. with the FDA for Rgk Daily Range Wheelchairs.

Pre-market Notification Details

Device IDK200135
510k NumberK200135
Device Name:RGK Daily Range Wheelchairs
ClassificationWheelchair, Mechanical
Applicant RGK Wheelchairs, Ltd. Units 8 B/C Ring RD 2 Burntwood Business Park Burntwood,  GB Ws7 3jq
ContactDevin Mcelroy
CorrespondentDevin Mcelroy
RGK Wheelchairs, Ltd. Units 8 B/C Ring RD 2 Burntwood Business Park Burntwood,  GB Ws7 3jq
Product CodeIOR  
CFR Regulation Number890.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-21
Decision Date2020-09-10

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