SWEDE ELITE, MECHANICAL WHEELCHAIR

Wheelchair, Mechanical

ETAC US, INC.

The following data is part of a premarket notification filed by Etac Us, Inc. with the FDA for Swede Elite, Mechanical Wheelchair.

Pre-market Notification Details

Device IDK883275
510k NumberK883275
Device Name:SWEDE ELITE, MECHANICAL WHEELCHAIR
ClassificationWheelchair, Mechanical
Applicant ETAC US, INC. 2233 WEST MILL RD. Glendale,  WI  53209
ContactCyndi Elsner
CorrespondentCyndi Elsner
ETAC US, INC. 2233 WEST MILL RD. Glendale,  WI  53209
Product CodeIOR  
CFR Regulation Number890.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-03
Decision Date1988-08-18

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