C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION

Vehicle, Motorized 3-wheeled

C.T.M. HOMECARE PRODUCT, INC.

The following data is part of a premarket notification filed by C.t.m. Homecare Product, Inc. with the FDA for C.t.m. Mobility Scooter, Model Hs-628, Invacare Orion.

Pre-market Notification Details

Device IDK091418
510k NumberK091418
Device Name:C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION
ClassificationVehicle, Motorized 3-wheeled
Applicant C.T.M. HOMECARE PRODUCT, INC. 29611 SIMMONS ROAD Eugene,  OR  97405
ContactLinda Bovard
CorrespondentLinda Bovard
C.T.M. HOMECARE PRODUCT, INC. 29611 SIMMONS ROAD Eugene,  OR  97405
Product CodeINI  
CFR Regulation Number890.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-13
Decision Date2009-07-06
Summary:summary

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