510(k) · Cleared

Cleared

Prestige-Mobie

K122749510(k) TraditionalCleared Dec 27, 2012111-day reviewClass II21 CFR 890.3800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Prestige Sporting Goods Co., Ltd. · INI Vehicle, Motorized 3-Wheeled

Cleared on Dec 27, 2012 as substantially equivalent to K110165 (Freerider Luggie Scooters, Inc., 2011) after a 111-day review. Its family tree reaches back 1 generation to 2011. 40 later devices descend from it.

Decided: Dec 27, 2012
Review: 111 days
Class: Class II
Product code: INI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K110165 (2011). 40 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK110165 Freerider Model Luggie Model 168-4ITFreerider Luggie Scooters, Inc. · 2011
This deviceK122749 Prestige-MobiePrestige Sporting Goods Co., Ltd. · 2012
Descendant · cites it directly · 38 of its ownK172440 Solax Electric Scooter, Models: S302121, S302131, S302141, S302151Dongguan Prestige Sporting Goods., Ltd. · 2018
Descendant · 2 generations on · 34 of its ownK182471 ScooterTianjin Kepler Vehicle Industry Co., Ltd. · 2019
Descendant · 3 generations on · 19 of its ownK220206 Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022
Descendant · 4 generations on · 12 of its ownK222507 Mobility Scooter (Models: W3431Q, W3431R)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
Descendant · 5 generations on · 11 of its ownK231428 Mobility Scooter (Models: W3431D)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2013high 13 (2026) · low 0 (2014)2026

Most influential descendants

Showing 5 of 40 · See all

K172440Solax Electric Scooter, Models: S302121, S302131, S302141, S302151Dongguan Prestige Sporting Goods., Ltd. · 2018 · cites it directly38descendants
K182471ScooterTianjin Kepler Vehicle Industry Co., Ltd. · 2019 · 2 generations on34descendants
K220206Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022 · 3 generations on19descendants
K222507Mobility Scooter (Models: W3431Q, W3431R)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023 · 4 generations on12descendants
K231428Mobility Scooter (Models: W3431D)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023 · 5 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K110165	Freerider Model Luggie Model 168-4IT	Freerider Luggie Scooters, Inc.	2011	—
0 (this device)	K122749	Prestige-Mobie	Prestige Sporting Goods Co., Ltd.	2012	—
+1	K172440	Solax Electric Scooter, Models: S302121, S302131, S302141, S302151	Dongguan Prestige Sporting Goods., Ltd.	2018	—
+2	K182471	Scooter	Tianjin Kepler Vehicle Industry Co., Ltd.	2019	—
+3	K220206	Mobility Scooter	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	2022	—
+4	K222507	Mobility Scooter (Models: W3431Q, W3431R)	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	2023	—
+5	K231428	Mobility Scooter (Models: W3431D)	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2018	1	0
2019	2	0
2021	2	0
2022	3	0
2023	5	0
2024	4	0
2025	9	0
2026	13	0

FIG. 1 — Lineage of K122749, 2011–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K110165	Freerider Model Luggie Model 168-4IT Summary page 1 …ed vehicle Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3 800 Product Code: TNT Classification: Class IT Predicate devices Luggie(K1 10165)1/ Freerider Corporation Intend use of device It is a motor driven, indoor and outdoor transportation vehicle with the intended…	Freerider Luggie Scooters, Inc.	2011	—

Also cleared against K110165: 3 other devices →

What descends from it? (40)

See all 40

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K172440	Solax Electric Scooter, Models: S302121, S302131, S302141, S302151	Dongguan Prestige Sporting Goods., Ltd.	2018	38
K131302	SOLAX	Dongguan Prestige Sporting Goods Co., Ltd.	2013	0

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?

Its one ancestor has no recall.
Of its descendants, K172440 (Dongguan Prestige Sporting Goods., Ltd., 2018) has gone furthest, with 38 descendants of its own.
3 other devices also cite its predicate K110165.

How does its category compare?

All INI devices

INI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · INI

21so far in 2026, the most since 2007

2007high 21 (2026) · low 1 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · INI

111in 2025

2007high 575 (2021) · low 28 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · INI

1in 2013

2007high 3 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · INI

26in 2025

2007high 567 (2014) · low 25 (2009)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 device is a motor driven, indoor and outdoor transportation vehicle with the

intended use to provide mobility to a disabled or elderly person limited to a seated

position.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122749 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122749: Prestige-Mobie.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122749

Report an extraction error

Are you the manufacturer?

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