510(k) · Cleared

Cleared

Solax Powered Wheelchair

K182576510(k) TraditionalCleared May 21, 2019244-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

Dongguan Prestige Sporting Goods Co., Ltd. · ITI Wheelchair, Powered

Cleared on May 21, 2019 as substantially equivalent to K011687 (Merits Health Products., Inc., 2001) after a 244-day review. Its family tree reaches back 1 generation to 2001.

Decided: May 21, 2019
Review: 244 days
Class: Class II
Product code: ITI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011687 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK011687 MP-3C Power Base Chair, Model MP3CMerits Health Products., Inc. · 2001 · Recalled
This deviceK182576 Solax Powered WheelchairDongguan Prestige Sporting Goods Co., Ltd. · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011687	MP-3C Power Base Chair, Model MP3C	Merits Health Products., Inc.	2001	1
0 (this device)	K182576	Solax Powered Wheelchair	Dongguan Prestige Sporting Goods Co., Ltd.	2019	—

FIG. 1 — Lineage of K182576, 2001–2019Source: 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

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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
*	K011687	MP-3C Power Base Chair, Model MP3C Summary page 4 …roducts, Inc.  Device Trade name: MP3C Power Base Chair, Model: MP3C  Common name: Powered Wheelchair  Classification name: Wheelchair, Powered  510K Number: K011687  Medical specialty (Panel): Physical Medicine  Regulation number: 890.3860  Product Code: ITI  Classification: Class…	Merits Health Products., Inc.	2001	1

Also cleared against K011687: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 a recall.
1 other device also cites its predicate K011687.

How does its category compare?

All ITI devices

ITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

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 intended use of the Solax Powered Wheelchair is to provide mobility to adults, limited to a seated position that have

capability to operate a few simple controls and the ability to control a powered wheelchair.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K182576 · printed Nov 5, 2026

Cite this page

510(k) Report. “K182576: Solax Powered Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182576

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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