FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50

Wheelchair, Mechanical

PDG PRODUCT DESIGN GROUP, INC.

The following data is part of a premarket notification filed by Pdg Product Design Group, Inc. with the FDA for Fuze Mechanical Wheelchair, Models T20 And T50.

Pre-market Notification Details

Device IDK063736
510k NumberK063736
Device Name:FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50
ClassificationWheelchair, Mechanical
Applicant PDG PRODUCT DESIGN GROUP, INC. 5905 FAWN LANE Cleveland,  OH  44141
ContactEdward A Kroll
CorrespondentEdward A Kroll
PDG PRODUCT DESIGN GROUP, INC. 5905 FAWN LANE Cleveland,  OH  44141
Product CodeIOR  
CFR Regulation Number890.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-18
Decision Date2007-01-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B829261 K063736 000
B829171 K063736 000
B829161 K063736 000
B829151 K063736 000
B829281 K063736 000

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