SWEDE CHAMP (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 Champ (wheelchair).

Pre-market Notification Details

Device IDK875034
510k NumberK875034
Device Name:SWEDE CHAMP (WHEELCHAIR)
ClassificationWheelchair, Mechanical
Applicant ETAC US, INC. 2233 WEST MILL RD. Glendale,  WI  53209
ContactMelody B Dill
CorrespondentMelody B Dill
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 Received1987-12-07
Decision Date1988-01-12

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