ROLLS 2000 SERIES WHEELCHAIR

Wheelchair, Mechanical

INVACARE CORP.

The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Rolls 2000 Series Wheelchair.

Pre-market Notification Details

Device IDK881762
510k NumberK881762
Device Name:ROLLS 2000 SERIES WHEELCHAIR
ClassificationWheelchair, Mechanical
Applicant INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria,  OH  44036
ContactJames R Thaler
CorrespondentJames R Thaler
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 Received1988-04-22
Decision Date1988-05-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.