510(k) · Cleared
ClearedOpti-Rider Deluxe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hansung Econet Co., Ltd. · INI Vehicle, Motorized 3-Wheeled
Cleared on Apr 12, 2004 as substantially equivalent to K983662 (Warepalmy Enterprise, LLC (Usa), 1998) and 1 other predicate after a 195-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Apr 12, 2004
- Review
- 195 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K920654 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920654 | Shoprider - TE889 | Pride Health Care, Inc. | 1992 | — |
| −1 | K983662 | C.T.M. Mobility Scooter, Model # HS-686 | Warepalmy Enterprise, LLC (Usa) | 1998 | — |
| 0 (this device) | K033116 | Opti-Rider Deluxe | Hansung Econet Co., Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in INI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new INI device
- #1 K231428 Mobility Scooter (Models: W3431D)score 23.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K983662 | C.T.M. Mobility Scooter, Model # HS-686Summary page 4…Common/Usual Name: Scooter Classification Name: Motorized three-wheeled vehicle 3. PREDICATE DEVICES * C.T.M. Mobility Scooter HS-686 (K983662) * Mega 4 Scooter (K982144) 4. DEVICE DESCRIPTION The proposed Opti-Rider Deluxe consists of a mo… | 1998 |
| * | K982144 | MEGA 4Summary page 4…sification Name: Motorized three-wheeled vehicle 3. PREDICATE DEVICES * C.T.M. Mobility Scooter HS-686 (K983662) * Mega 4 Scooter (K982144) 4. DEVICE DESCRIPTION The proposed Opti-Rider Deluxe consists of a motorized, four-wheeled chassis with… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · INI
21so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · INI
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · INI
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · INI
26in 2025
MAUDE reports naming product code INI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 29 | 2 | 64 |
| 2008 | 7 | 28 | 0 | 29 |
| 2009 | 12 | 41 | 0 | 25 |
| 2010 | 5 | 46 | 3 | 56 |
| 2011 | 5 | 130 | 3 | 70 |
| 2012 | 1 | — | 0 | 172 |
| 2013 | 2 | — | 1 | 454 |
| 2014 | 1 | — | 0 | 567 |
| 2015 | 9 | 202 | 0 | 151 |
| 2016 | 1 | — | 0 | 76 |
| 2017 | 5 | 191 | 0 | 45 |
| 2018 | 3 | 266 | 0 | 51 |
| 2019 | 4 | 298 | 0 | 25 |
| 2020 | 1 | — | 0 | 26 |
| 2021 | 5 | 575 | 0 | 41 |
| 2022 | 6 | 159 | 0 | 41 |
| 2023 | 9 | 123 | 0 | 32 |
| 2024 | 8 | 137 | 0 | 31 |
| 2025 | 15 | 111 | 0 | 26 |
| 2026 | 21 | 108 | 0 | — |
What is it indicated for?
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…
Read the full statement (113 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033116: Opti-Rider Deluxe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033116
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026