510(k) · Cleared

Cleared

M71 Power Wheelchair

K012927510(k) TraditionalCleared Sep 19, 200119-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

Invacare Corp. · ITI Wheelchair, Powered

Cleared on Sep 19, 2001 as substantially equivalent to K991168 (Invacare Corp., 1999) and 2 other predicates after a 19-day review. Its family tree reaches back 3 generations to 1990. 2 later devices descend from it.

Decided: Sep 19, 2001
Review: 19 days
Class: Class II
Product code: ITI
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K900565 (1990). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK900565 Invacare Power 9000 Series WheelchairInvacare Corp. · 1990
2 generations backK982064 Action Storm Ranger II, Action Storm Power 9000Invacare Corp. · 1998
1 generation backK991168 Arrow FWD Power WheelchairInvacare Corp. · 1999 · Recalled
This deviceK012927 M71 Power WheelchairInvacare Corp. · 2001
Descendant · cites it directly · 1 of its ownK021680 Invacare Powered Wheelchairs, Models M50, M51, M71 & M91Invacare Corp. · 2002 · Recalled
Descendant · 2 generations on · 0 of its ownK080385 Cruiser PP5500 Challenger Powered WheelchairE1 Ent., Inc. · 2008

Most influential descendants

Showing 2 of 2 · See all

K021680Invacare Powered Wheelchairs, Models M50, M51, M71 & M91Invacare Corp. · 2002 · cites it directly1descendant
K080385Cruiser PP5500 Challenger Powered WheelchairE1 Ent., Inc. · 2008 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K900565	Invacare Power 9000 Series Wheelchair	Invacare Corp.	1990	—
−2	K982064	Action Storm Ranger II, Action Storm Power 9000	Invacare Corp.	1998	—
−1	K991168	Arrow FWD Power Wheelchair	Invacare Corp.	1999	2
0 (this device)	K012927	M71 Power Wheelchair	Invacare Corp.	2001	—
+1	K021680	Invacare Powered Wheelchairs, Models M50, M51, M71 & M91	Invacare Corp.	2002	6
+2	K080385	Cruiser PP5500 Challenger Powered Wheelchair	E1 Ent., Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2008	1	0

FIG. 1 — Lineage of K012927, 1990–2008Source: 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? (3)

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
*	K991168	Arrow FWD Power Wheelchair Summary page 1 …on or Usual Name Power Wheelchair Classification Name Wheelchair, Powered \ Predicate Devices Invacare Corporations’ Action Arrow Front Wheel Drive Power Wheelchairs (K991168 June 25, 1999), Invacare Corporations’ Ranger II M6 Power Wheelchair (K002157, August 25, 2000), and Permobil’s Chairman Front Wh…	Invacare Corp.	1999	2
*	K002157	Ranger II M6, Model in-888WNL Summary page 1 …Predicate Devices Invacare Corporations’ Action Arrow Front Wheel Drive Power Wheelchairs (K991168 June 25, 1999), Invacare Corporations’ Ranger II M6 Power Wheelchair (K002157, August 25, 2000), and Permobil’s Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997). Intended…	Invacare Corp.	2000	—
*	K960951	Permobil Chairman L/CS 8 Summary page 1 …irs (K991168 June 25, 1999), Invacare Corporations’ Ranger II M6 Power Wheelchair (K002157, August 25, 2000), and Permobil’s Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997). Intended Use The intended use of the Invacare Model M71 Power Wheelchair is to provide mobility…	Permobil AB	1997	—

Also cleared against K991168: 3 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K021680	Invacare Powered Wheelchairs, Models M50, M51, M71 & M91	Invacare Corp.	2002	1

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?

The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
1 of the 5 ancestors has a recall of any class.
Of its descendants, K021680 (Invacare Corp., 2002) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K991168.

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 intended use of the Invacare M71 Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating 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/K012927 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012927: M71 Power Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012927

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026