510(k) · Cleared

Cleared

Permobil Chairman L/CS 8

K960951510(k) TraditionalCleared Apr 30, 1997415-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

Permobil AB · ITI Wheelchair, Powered

Cleared on Apr 30, 1997 after a 415-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 53 devices in its family, counting itself, have a Class I recall. 52 later devices descend from it.

Decided: Apr 30, 1997
Review: 415 days
Class: Class II
Product code: ITI
Recalls: None
Predicates: 0

52 later devices descend from it, 8 citing it directly. 2 of the 53 devices in this family, counting this one, have a Class I recall.

This deviceK960951 Permobil Chairman L/CS 8Permobil AB · 1997
Descendant · cites it directly · 32 of its ownK991658 Permobil Powered Wheelchair 1280Permobil AB · 1999 · Recalled
Descendant · 2 generations on · 22 of its ownK041219 ElectroPermobil AB · 2004 · Recalled
Descendant · 3 generations on · 21 of its ownK071650 C350 Powered WheelchairPermobil AB · 2007 · Recalled
Descendant · cites it directly · 18 of its ownK982064 Action Storm Ranger II, Action Storm Power 9000Invacare Corp. · 1998
Descendant · cites it directly · 17 of its ownK991168 Arrow FWD Power WheelchairInvacare Corp. · 1999 · Recalled

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

1998high 5 (2015) · low 0 (2000)2026

Class I recalls in this family

K213383 WHILL Model C27 generations on · 2021
K221438 WHILL Model F8 generations on · 2022

Most influential descendants

Showing 5 of 52 · See all

K991658Permobil Powered Wheelchair 1280Permobil AB · 1999 · cites it directly32descendants
K041219ElectroPermobil AB · 2004 · 2 generations on22descendants
K071650C350 Powered WheelchairPermobil AB · 2007 · 3 generations on21descendants
K982064Action Storm Ranger II, Action Storm Power 9000Invacare Corp. · 1998 · cites it directly18descendants
K991168Arrow FWD Power WheelchairInvacare Corp. · 1999 · cites it directly17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K960951	Permobil Chairman L/CS 8	Permobil AB	1997	—
+1	K991658	Permobil Powered Wheelchair 1280	Permobil AB	1999	5
+2	K041219	Electro	Permobil AB	2004	4
+3	K071650	C350 Powered Wheelchair	Permobil AB	2007	3
+1	K982064	Action Storm Ranger II, Action Storm Power 9000	Invacare Corp.	1998	—
+1	K991168	Arrow FWD Power Wheelchair	Invacare Corp.	1999	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	3	0
2001	2	0
2002	3	0
2003	1	0
2004	3	0
2005	2	0
2007	1	0
2008	4	0
2009	1	0
2010	1	0
2011	2	0
2012	1	0
2013	1	0
2015	5	0
2016	1	0
2017	1	0
2018	2	0
2019	3	0
2020	2	0
2021	4	1
2022	2	1
2023	2	0
2024	2	0
2026	2	0

FIG. 1 — Lineage of K960951, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (52)

See all 52

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

Number	Device	Applicant	Decided	Descendants
K991658	Permobil Powered Wheelchair 1280	Permobil AB	1999	32
K982064	Action Storm Ranger II, Action Storm Power 9000	Invacare Corp.	1998	18
K991168	Arrow FWD Power Wheelchair	Invacare Corp.	1999	17
K012909	Xterra GT Power Wheelchair	Invacare Corp.	2001	14
K023589	Storm TDX Power Wheelchair	Invacare Corp.	2002	9
K012927	M71 Power Wheelchair	Invacare Corp.	2001	2
K991119	Tilt/Recliner for Power Wheelchairs, Model 2G	Invacare Corp.	1999	2
K041211	Powered Wheelchair, Model C-1000	Otto Bock Healthcare LP	2004	1

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K213383WHILL Model C2Whill, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
K221438WHILL Model FWhill, Inc. · 2022 · 8 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K991658 (Permobil AB, 1999) has gone furthest, with 32 descendants of its own.

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	—

https://510kreport.com/device/K960951 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960951: Permobil Chairman L/CS 8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960951

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026