C.T.M. MOBILITY SCOOTER, MODEL HS-235

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-235.

Pre-market Notification Details

Device IDK032918
510k NumberK032918
Device Name:C.T.M. MOBILITY SCOOTER, MODEL HS-235
ClassificationVehicle, Motorized 3-wheeled
Applicant C.T.M. HOMECARE PRODUCT, INC. 3636 E. COLUMBINE DR. Phoenix,  AZ  85032
ContactRobert S Mcquate
CorrespondentRobert S Mcquate
C.T.M. HOMECARE PRODUCT, INC. 3636 E. COLUMBINE DR. Phoenix,  AZ  85032
Product CodeINI  
CFR Regulation Number890.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-22
Decision Date2003-10-06
Summary:summary

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