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510(k) Data Aggregation
K Number
K033116Device Name
OPTI-RIDER DELUXE
Manufacturer
Date Cleared
2004-04-12
(195 days)
Product Code
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
HANSUNG ECONET CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Opti-Rider Deluxe is a motorized, battery-operated, fourwheel scooter used for transportation by disabled persons.
Device Description
The proposed Opti-Rider Deluxe consists of a motorized, four-wheeled chassis with batteries, drive unit, steering column, braking system, and electronics module for operational control of the vehicle. The user sits in a seat mounted on the chassis and operates the scooter via hand controls and a console mounted on the steering column.
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