510(k) · Cleared

Cleared

Permobil M300 / M400

K103477510(k) TraditionalCleared Mar 3, 201197-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 Mar 3, 2011 as substantially equivalent to K071650 (Permobil AB, 2007) after a 97-day review. Its family tree reaches back 4 generations to 1997. 2 of the 18 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it.

Decided: Mar 3, 2011
Review: 97 days
Class: Class II
Product code: ITI
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K960951 (1997). 5 ancestors in all. 12 later devices descend from it, 2 citing it directly. 2 of the 18 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK960951 Permobil Chairman L/CS 8Permobil AB · 1997
3 generations backK991658 Permobil Powered Wheelchair 1280Permobil AB · 1999 · Recalled
2 generations backK041219 ElectroPermobil AB · 2004 · Recalled
1 generation backK071650 C350 Powered WheelchairPermobil AB · 2007 · Recalled
This deviceK103477 Permobil M300 / M400Permobil AB · 2011
Descendant · cites it directly · 9 of its ownK143180 F3Permobil AB · 2015
Descendant · 2 generations on · 7 of its ownK153543 WHILL Model MWhill, Inc. · 2016
Descendant · 3 generations on · 6 of its ownK213383 WHILL Model C2Whill, Inc. · 2021 · Recalled (Class I)
Descendant · 4 generations on · 3 of its ownK223393 Electric WheelchairShanghai Bangbang Robotics Co., Ltd. · 2023
Descendant · 5 generations on · 2 of its ownK231868 Electric Wheelchair (Robooter E40), Model name: BBR-E40-01Shanghai Bangbang Robotics Co., Ltd. · 2023

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2015high 2 (2015) · low 0 (2017)2026

Class I recalls in this family

K213383 WHILL Model C23 generations on · 2021
K221438 WHILL Model F4 generations on · 2022

Most influential descendants

Showing 5 of 12 · See all

K143180F3Permobil AB · 2015 · cites it directly9descendants
K153543WHILL Model MWhill, Inc. · 2016 · 2 generations on7descendants
K213383WHILL Model C2Whill, Inc. · 2021 · 3 generations on6descendants
K223393Electric WheelchairShanghai Bangbang Robotics Co., Ltd. · 2023 · 4 generations on3descendants
K231868Electric Wheelchair (Robooter E40), Model name: BBR-E40-01Shanghai Bangbang Robotics Co., Ltd. · 2023 · 5 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K960951	Permobil Chairman L/CS 8	Permobil AB	1997	—
−3	K991658	Permobil Powered Wheelchair 1280	Permobil AB	1999	5
−2	K041219	Electro	Permobil AB	2004	4
−1	K071650	C350 Powered Wheelchair	Permobil AB	2007	3
0 (this device)	K103477	Permobil M300 / M400	Permobil AB	2011	—
+1	K143180	F3	Permobil AB	2015	—
+2	K153543	WHILL Model M	Whill, Inc.	2016	—
+3	K213383	WHILL Model C2	Whill, Inc.	2021	Class I
+4	K223393	Electric Wheelchair	Shanghai Bangbang Robotics Co., Ltd.	2023	—
+5	K231868	Electric Wheelchair (Robooter E40), Model name: BBR-E40-01	Shanghai Bangbang Robotics Co., Ltd.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	2	0
2016	1	0
2019	1	0
2021	1	1
2022	2	1
2023	2	0
2024	1	0
2026	2	0

FIG. 1 — Lineage of K103477, 1997–2026Source: 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.

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

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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
*	K071650	C350 Powered Wheelchair Summary page 1 …red: October, 20 10 Device name; M300 & M400 Classification Name: Powered wheelchair Predicate Devices: C350 ( K07 1650) manufactured by Permobil All Intended use: Ihe intended use of the M300 & M400 powered wheelchair is to pr…	Permobil AB	2007	3

Also cleared against K071650: 3 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K143180	F3	Permobil AB	2015	9
K143014	F5	Permobil AB	2015	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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
K221438WHILL Model FWhill, Inc. · 2022 · 4 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
3 of the 5 ancestors have a recall of any class.
Of its descendants, K143180 (Permobil AB, 2015) has gone furthest, with 9 descendants of its own.
3 other devices also cite its predicate K071650.

How does its category compare?

All ITI devices

ITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 CM300/400 series of the powered wheelchair is to

provide indoor and outdoor mobility to persons limited to a seating position

that are capable of operating a powered wheelchair.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103477 · printed Nov 5, 2026

Cite this page

510(k) Report. “K103477: Permobil M300 / M400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103477

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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