P.R.O. CG Manual Wheelchair

Wheelchair, Mechanical

FREEDOM DESIGNS, INC.

The following data is part of a premarket notification filed by Freedom Designs, Inc. with the FDA for P.r.o. Cg Manual Wheelchair.

Pre-market Notification Details

Device IDK151893
510k NumberK151893
Device Name:P.R.O. CG Manual Wheelchair
ClassificationWheelchair, Mechanical
Applicant FREEDOM DESIGNS, INC. 2241 MADERA ROAD Simi Valley,  CA  93065
ContactNancy F Schmidt
CorrespondentNancy F Schmidt
FREEDOM DESIGNS, INC. 2241 MADERA ROAD Simi Valley,  CA  93065
Product CodeIOR  
CFR Regulation Number890.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-10
Decision Date2015-10-22
Summary:summary

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