510(k) · Cleared

Cleared

Heartway Lightweight Power Mobility Scooter, S33

K071007510(k) TraditionalCleared Apr 19, 200710-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

Heartway Medical Products Co., Ltd. · INI Vehicle, Motorized 3-Wheeled

Cleared on Apr 19, 2007 as substantially equivalent to K032488 (Wu'S Tech Co., Ltd., 2003) after a 10-day review. Its family tree reaches back 1 generation to 2003. 25 later devices descend from it.

Decided: Apr 19, 2007
Review: 10 days
Class: Class II
Product code: INI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K032488 (2003). 25 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK032488 Wu's 3-Wheeled Neo Scooter, WT-T3DWu'S Tech Co., Ltd. · 2003
This deviceK071007 Heartway Lightweight Power Mobility Scooter, S33Heartway Medical Products Co., Ltd. · 2007
Descendant · cites it directly · 12 of its ownK101142 Heartway Lightweight Power Mobility Scooter, S34Heartway Medical Products Co., Ltd. · 2010
Descendant · cites it directly · 11 of its ownK072104 Heartway Power Mobility Scooter, PF6Heartway Medical Products Co., Ltd. · 2007
Descendant · 2 generations on · 9 of its ownK150987 HEARTWAY Power Mobility Scooter, BRIO S19Heartway Medical Products Co., Ltd. · 2015
Descendant · 2 generations on · 6 of its ownK073044 Heartway Power Mobility Scooter, Model PT7Heartway Medical Products Co., Ltd. · 2007
Descendant · 3 generations on · 5 of its ownK220227 Auto Folding Scooter, S21FHeartway Medical Products Co., Ltd. · 2022

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2007high 5 (2015) · low 0 (2011)2026

Most influential descendants

Showing 5 of 25 · See all

K101142Heartway Lightweight Power Mobility Scooter, S34Heartway Medical Products Co., Ltd. · 2010 · cites it directly12descendants
K072104Heartway Power Mobility Scooter, PF6Heartway Medical Products Co., Ltd. · 2007 · cites it directly11descendants
K150987HEARTWAY Power Mobility Scooter, BRIO S19Heartway Medical Products Co., Ltd. · 2015 · 2 generations on9descendants
K073044Heartway Power Mobility Scooter, Model PT7Heartway Medical Products Co., Ltd. · 2007 · 2 generations on6descendants
K220227Auto Folding Scooter, S21FHeartway Medical Products Co., Ltd. · 2022 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K032488	Wu's 3-Wheeled Neo Scooter, WT-T3D	Wu'S Tech Co., Ltd.	2003	—
0 (this device)	K071007	Heartway Lightweight Power Mobility Scooter, S33	Heartway Medical Products Co., Ltd.	2007	—
+1	K101142	Heartway Lightweight Power Mobility Scooter, S34	Heartway Medical Products Co., Ltd.	2010	—
+1	K072104	Heartway Power Mobility Scooter, PF6	Heartway Medical Products Co., Ltd.	2007	—
+2	K150987	HEARTWAY Power Mobility Scooter, BRIO S19	Heartway Medical Products Co., Ltd.	2015	—
+2	K073044	Heartway Power Mobility Scooter, Model PT7	Heartway Medical Products Co., Ltd.	2007	—
+3	K220227	Auto Folding Scooter, S21F	Heartway Medical Products Co., Ltd.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2008	1	0
2009	3	0
2010	2	0
2014	1	0
2015	5	0
2019	1	0
2022	2	0
2023	1	0
2024	2	0
2025	1	0
2026	4	0

FIG. 1 — Lineage of K071007, 2003–2026Source: 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
*	K032488	Wu's 3-Wheeled Neo Scooter, WT-T3D Summary page 1 …d their chargers - requirements and test methods) Legally marketed device for substantial equivalence comparison: WU'S 3-WHEELED NEO SCOOTER, WT-T3D (K032488) DI === Page…	Wu'S Tech Co., Ltd.	2003	—

Also cleared against K032488: 5 other devices →

What descends from it? (25)

See all 25

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

Number	Device	Applicant	Decided	Descendants
K101142	Heartway Lightweight Power Mobility Scooter, S34	Heartway Medical Products Co., Ltd.	2010	12
K072104	Heartway Power Mobility Scooter, PF6	Heartway Medical Products Co., Ltd.	2007	11

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, K101142 (Heartway Medical Products Co., Ltd., 2010) has gone furthest, with 12 descendants of its own.
5 other devices also cite its predicate K032488.

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. 2007, 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 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/K071007 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071007: Heartway Lightweight Power Mobility Scooter, S33.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071007

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