510(k) · Cleared

Cleared

Pro Walker ML-300 Foldable Wheelchair

K041337510(k) TraditionalCleared May 28, 20049-day reviewClass I21 CFR 890.3850

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

Pro Walker, Inc. · IOR Wheelchair, Mechanical

Cleared on May 28, 2004 as substantially equivalent to K020472 (Taiwan Armada Enterprise Co., Ltd., 2002) after a 9-day review. Its family tree reaches back 1 generation to 2002. 30 later devices descend from it.

Decided: May 28, 2004
Review: 9 days
Class: Class I
Product code: IOR
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K020472 (2002). 30 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK020472 Biotech Manual Wheelchair B900 Super Light WheelchairTaiwan Armada Enterprise Co., Ltd. · 2002
This deviceK041337 Pro Walker ML-300 Foldable WheelchairPro Walker, Inc. · 2004
Descendant · cites it directly · 22 of its ownK050290 Lerado, CoscoLerado Oversea Ltd. Twn Branch (Bvi) · 2005
Descendant · 2 generations on · 20 of its ownK050708 Lerado, Avanticare Mechanical Wheelchair, MR-9000Lerado Oversea Ltd. Twn Branch (Bvi) · 2005
Descendant · 3 generations on · 18 of its ownK051482 Jan Mao Wheelchair, Model JMC612-F18EPPJan Mao Industries Co., Ltd. · 2005
Descendant · 4 generations on · 17 of its ownK062218 Jan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPPJan Mao Industries Co., Ltd. · 2006
Descendant · 5 generations on · 12 of its ownK101999 Kaiyang Steel WheelchairGuangdong Kaiyang Medical Technology Co., Ltd. · 2010

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2005high 5 (2005) · low 0 (2008)2026

Most influential descendants

Showing 5 of 30 · See all

K050290Lerado, CoscoLerado Oversea Ltd. Twn Branch (Bvi) · 2005 · cites it directly22descendants
K050708Lerado, Avanticare Mechanical Wheelchair, MR-9000Lerado Oversea Ltd. Twn Branch (Bvi) · 2005 · 2 generations on20descendants
K051482Jan Mao Wheelchair, Model JMC612-F18EPPJan Mao Industries Co., Ltd. · 2005 · 3 generations on18descendants
K062218Jan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPPJan Mao Industries Co., Ltd. · 2006 · 4 generations on17descendants
K101999Kaiyang Steel WheelchairGuangdong Kaiyang Medical Technology Co., Ltd. · 2010 · 5 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K020472	Biotech Manual Wheelchair B900 Super Light Wheelchair	Taiwan Armada Enterprise Co., Ltd.	2002	—
0 (this device)	K041337	Pro Walker ML-300 Foldable Wheelchair	Pro Walker, Inc.	2004	—
+1	K050290	Lerado, Cosco	Lerado Oversea Ltd. Twn Branch (Bvi)	2005	—
+2	K050708	Lerado, Avanticare Mechanical Wheelchair, MR-9000	Lerado Oversea Ltd. Twn Branch (Bvi)	2005	—
+3	K051482	Jan Mao Wheelchair, Model JMC612-F18EPP	Jan Mao Industries Co., Ltd.	2005	—
+4	K062218	Jan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPP	Jan Mao Industries Co., Ltd.	2006	—
+5	K101999	Kaiyang Steel Wheelchair	Guangdong Kaiyang Medical Technology Co., Ltd.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	5	0
2006	5	0
2007	1	0
2010	2	0
2012	3	0
2013	1	0
2014	2	0
2015	1	0
2016	3	0
2017	1	0
2019	2	0
2020	1	0
2022	1	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K041337, 2002–2026Source: 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 IOR? 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 IOR device

#1 K201461 Manual Wheelchair, Model A011score 20.0 · 3 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
*	K020472	Biotech Manual Wheelchair B900 Super Light Wheelchair Summary page 1 …ndards as indicated in section B page 7-1-7-5. Legally marketed device for substantial equivalence comparison: BIOTECH B900 SUPER LIGHT Wheelchair ( K020472). JNo. PRO WALKER INC.…	Taiwan Armada Enterprise Co., Ltd.	2002	—

Also cleared against K020472: 1 other device →

What descends from it? (30)

See all 30

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

Number	Device	Applicant	Decided	Descendants
K050290	Lerado, Cosco	Lerado Oversea Ltd. Twn Branch (Bvi)	2005	22
K060251	WH Convertible Lightweght Wheelchair, Model WHL100	Well Home Health Products Co.	2006	6

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, K050290 (Lerado Oversea Ltd. Twn Branch (Bvi), 2005) has gone furthest, with 22 descendants of its own.
1 other device also cites its predicate K020472.

How does its category compare?

All IOR devices

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

FDA decisions per year · IOR

17so far in 2026, the most since 2007

2007high 17 (2026) · low 2 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IOR

91in 2025

2007high 233 (2013) · low 32 (2008)2026

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

Recalls per year · IOR

1in 2021

2007high 6 (2011) · low 0 (2010)2026

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

Adverse event reports per year · IOR

135in 2025

2007high 5,082 (2014) · low 36 (2007)2025

MAUDE reports naming product code IOR, 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	5	38	1	36
2008	13	32	3	62
2009	4	43	2	54
2010	12	81	0	69
2011	6	58	6	232
2012	11	176	3	1,238
2013	7	233	3	4,674
2014	7	211	3	5,082
2015	3	104	0	4,472
2016	10	135	1	1,860
2017	7	209	0	49
2018	3	203	0	58
2019	6	160	0	53
2020	2	—	0	43
2021	2	—	1	59
2022	4	150	0	37
2023	9	61	0	165
2024	4	65	0	138
2025	7	91	0	135
2026	17	103	0	—

What is it indicated for?

The device is intended for medical purposes to provide mobility to persoi~ restricted to a sitting position.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041337 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041337: Pro Walker ML-300 Foldable Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041337

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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