TRACER SERIES MANUAL WHEELCHAIRS

Wheelchair, Mechanical

INVACARE CORP.

The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Tracer Series Manual Wheelchairs.

Pre-market Notification Details

Device IDK935398
510k NumberK935398
Device Name:TRACER SERIES MANUAL WHEELCHAIRS
ClassificationWheelchair, Mechanical
Applicant INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria,  OH  44036
ContactEdward A Kroll
CorrespondentEdward A Kroll
INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria,  OH  44036
Product CodeIOR  
CFR Regulation Number890.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-11-09
Decision Date1994-03-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841447103042 K935398 000
00841447103035 K935398 000

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