# K033116: Opti-Rider Deluxe

- Pathway: 510(k) (Traditional)
- Applicant: Hansung Econet Co., Ltd.
- Decided: Apr 12, 2004 after 195 days
- Product code: INI (Vehicle, Motorized 3-Wheeled)
- Device class: 2
- Regulation: 21 CFR 890.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920654 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983662: C.T.M. Mobility Scooter, Model # HS-686, Warepalmy Enterprise, LLC (Usa) (1998) Summary page 4.
- K982144: MEGA 4, Mega Motion, Inc. (1999) Summary page 4.

## Indications for use
The Opti-Rider Deluxe is a motorized, battery-operated, four- wheel scooter used for transportation by disabled persons. The principles of operation of the proposed Opti-Rider Deluxe are identical to those of the predicate C.T.M. Mobility Scooter HS-686 scooter and other matorized vehicles legally marketed in the. U.S. for use by disabled persons”for transportation purposes. The Opti-Rider Deluxe, and other motorized four- wheelad vehicles, consists of a motorized chassis with a batterv, drive unit, steering column, and electronics module. The user sits in a seat mounted on the chassis and operates the scooter via handpieces mounted on the steering column that also contains the console for control of the speed, emergency brake, and other features.

Source page: https://510kreport.com/device/K033116
Methodology: https://510kreport.com/methodology