510(k) · Cleared

Cleared

BE-Mobile 3-Wheeled Electric Scooter, Model DK S320

K033241510(k) TraditionalCleared Nov 10, 200335-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

Tung Keng Enterprise Co., Ltd. · INI Vehicle, Motorized 3-Wheeled

Cleared on Nov 10, 2003 as substantially equivalent to K023010 (Aeolus International Corporation, 2002) after a 35-day review. Its family tree reaches back 1 generation to 2002. 8 later devices descend from it.

Decided: Nov 10, 2003
Review: 35 days
Class: Class II
Product code: INI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K023010 (2002). 8 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK023010 Sniff Position Pillows/Popitz PillowsAeolus International Corporation · 2002
This deviceK033241 BE-Mobile 3-Wheeled Electric Scooter, Model DK S320Tung Keng Enterprise Co., Ltd. · 2003
Descendant · cites it directly · 4 of its ownK050792 Landlex, Model S300XCycling and Health Tech. Industry R&D Center · 2005
Descendant · 2 generations on · 3 of its ownK052378 Proasia, Model L3402Proasia Limited · 2005
Descendant · 2 generations on · 2 of its ownK060042 Landlex, Model P100XBesteam Technology, Inc. · 2006
Descendant · 3 generations on · 1 of its ownK062676 Ruike, Model 3331Shanghai Ruike Sports Goods Co., Ltd. · 2006
Descendant · cites it directly · 1 of its ownK051131 VCS S3TCycling and Health Tech. Industry R&D Center/Chc · 2005

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2005high 4 (2005) · low 0 (2007)2026

Most influential descendants

Showing 5 of 8 · See all

K050792Landlex, Model S300XCycling and Health Tech. Industry R&D Center · 2005 · cites it directly4descendants
K052378Proasia, Model L3402Proasia Limited · 2005 · 2 generations on3descendants
K060042Landlex, Model P100XBesteam Technology, Inc. · 2006 · 2 generations on2descendants
K062676Ruike, Model 3331Shanghai Ruike Sports Goods Co., Ltd. · 2006 · 3 generations on1descendant
K051131VCS S3TCycling and Health Tech. Industry R&D Center/Chc · 2005 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K023010	Sniff Position Pillows/Popitz Pillows	Aeolus International Corporation	2002	—
0 (this device)	K033241	BE-Mobile 3-Wheeled Electric Scooter, Model DK S320	Tung Keng Enterprise Co., Ltd.	2003	—
+1	K050792	Landlex, Model S300X	Cycling and Health Tech. Industry R&D Center	2005	—
+2	K052378	Proasia, Model L3402	Proasia Limited	2005	—
+2	K060042	Landlex, Model P100X	Besteam Technology, Inc.	2006	—
+3	K062676	Ruike, Model 3331	Shanghai Ruike Sports Goods Co., Ltd.	2006	—
+1	K051131	VCS S3T	Cycling and Health Tech. Industry R&D Center/Chc	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	4	0
2006	2	0
2010	1	0
2011	1	0

FIG. 1 — Lineage of K033241, 2002–2011Source: 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

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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
*	K023010	Sniff Position Pillows/Popitz Pillows	Aeolus International Corporation	2002	—

Also cleared against K023010: 1 other device →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K050792	Landlex, Model S300X	Cycling and Health Tech. Industry R&D Center	2005	4
K051131	VCS S3T	Cycling and Health Tech. Industry R&D Center/Chc	2005	1
K051130	VCS S3Y	Cycling and Health Tech. Industry R&D Center/Chc	2005	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, K050792 (Cycling and Health Tech. Industry R&D Center, 2005) has gone furthest, with 4 descendants of its own.
1 other device also cites its predicate K023010.

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.

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 intended for medical purposes to provide mobility to persons restricted to a sitting position.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033241 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033241: BE-Mobile 3-Wheeled Electric Scooter, Model DK S320.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033241

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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