510(k) · Cleared

Cleared

Taiwan King Strong Powered Wheelchair, TP 01

K033100510(k) TraditionalCleared Dec 2, 200364-day reviewClass II21 CFR 890.3860

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

Taiwan King Strong Co., Ltd. · ITI Wheelchair, Powered

Cleared on Dec 2, 2003 as substantially equivalent to K030356 (Comfort Orthopedic Co., Ltd., 2003) after a 64-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.

Decided: Dec 2, 2003
Review: 64 days
Class: Class II
Product code: ITI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K030356 (2003). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK030356 Comfort Powered Wheelchair, Traveller LY-EB 103Comfort Orthopedic Co., Ltd. · 2003
This deviceK033100 Taiwan King Strong Powered Wheelchair, TP 01Taiwan King Strong Co., Ltd. · 2003
Descendant · cites it directly · 0 of its ownK050011 Wu's Powered Wheelchair, Mambo F 120Wu'S Tech Co., Ltd. · 2005

Most influential descendants

Showing 1 of 1 · See all

K050011Wu's Powered Wheelchair, Mambo F 120Wu'S Tech Co., Ltd. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K030356	Comfort Powered Wheelchair, Traveller LY-EB 103	Comfort Orthopedic Co., Ltd.	2003	—
0 (this device)	K033100	Taiwan King Strong Powered Wheelchair, TP 01	Taiwan King Strong Co., Ltd.	2003	—
+1	K050011	Wu's Powered Wheelchair, Mambo F 120	Wu'S Tech Co., Ltd.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K033100, 2003–2005Source: 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 ITI? 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 ITI device

#1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 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
*	K030356	Comfort Powered Wheelchair, Traveller LY-EB 103 Summary page 1 …chargers - requirements and test methods) Legally marketed device for substantial equivalence comparison: COMFORT Powered Wheelchair, Traveller LY-EB 103 (K030356) TAIWAN KING STRONG CO., LTD. No. 144, Dong Ming Road, T…	Comfort Orthopedic Co., Ltd.	2003	—

Also cleared against K030356: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050011	Wu's Powered Wheelchair, Mambo F 120	Wu'S Tech Co., Ltd.	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, K050011 (Wu'S Tech Co., Ltd., 2005) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K030356.

How does its category compare?

All ITI devices

ITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ITI

29in 2025

2007high 38 (2024) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITI

90in 2025

2007high 278 (2020) · low 42 (2007)2026

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

Recalls per year · ITI

13so far in 2026, the most since 2007

2007high 13 (2026) · low 0 (2011)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · ITI

647in 2025

2007high 8,741 (2013) · low 123 (2007)2025

MAUDE reports naming product code ITI, 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	42	3	123
2008	9	49	3	133
2009	7	63	1	183
2010	6	46	2	157
2011	4	101	0	525
2012	6	155	1	2,919
2013	5	177	0	8,741
2014	5	213	0	7,282
2015	10	174	0	4,685
2016	6	173	1	1,575
2017	4	159	2	301
2018	4	117	0	273
2019	3	244	0	264
2020	6	278	0	205
2021	13	209	3	166
2022	16	96	0	135
2023	8	128	0	223
2024	38	125	1	146
2025	29	90	3 (2)	647
2026	36	108	13	—

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/K033100 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033100: Taiwan King Strong Powered Wheelchair, TP 01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033100

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