C.T.M. MOBILITY SCOOTER, MODEL # HS-666

Vehicle, Motorized 3-wheeled

WAREPALMY ENTERPRISE LLC (USA)

The following data is part of a premarket notification filed by Warepalmy Enterprise Llc (usa) with the FDA for C.t.m. Mobility Scooter, Model # Hs-666.

Pre-market Notification Details

Device IDK983663
510k NumberK983663
Device Name:C.T.M. MOBILITY SCOOTER, MODEL # HS-666
ClassificationVehicle, Motorized 3-wheeled
Applicant WAREPALMY ENTERPRISE LLC (USA) 3636 EAST COLUMBINE DR. Phoenix,  AZ  85032 -7372
ContactRobert S Mcquate
CorrespondentRobert S Mcquate
WAREPALMY ENTERPRISE LLC (USA) 3636 EAST COLUMBINE DR. Phoenix,  AZ  85032 -7372
Product CodeINI  
CFR Regulation Number890.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-19
Decision Date1998-12-18
Summary:summary

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