DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000

Wheelchair, Powered

DANE TECHNOLOGIES

The following data is part of a premarket notification filed by Dane Technologies with the FDA for Dane Technologies Wheelchair Mover, Model Wm 2000.

Pre-market Notification Details

Device IDK073701
510k NumberK073701
Device Name:DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000
ClassificationWheelchair, Powered
Applicant DANE TECHNOLOGIES 7105 NORTHLAND TERRACE Brooklyn Park,  MN  55428
ContactOliver Pittenger
CorrespondentDaniel W Lehtonen
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-12-31
Decision Date2008-01-28
Summary:summary

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