510(k) · Cleared

Recalled · Class II · 2013

Storm Series, Power 9000 Series and Power Tiger with Gyroscope Control

K993413510(k) TraditionalCleared Dec 15, 199964-day reviewClass II21 CFR 890.3860Recalls 2

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 Dec 15, 1999 as substantially equivalent to K940051 (Invacare Corp., 1994) and 2 other predicates after a 64-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it. It has been recalled 2 times.

Decided: Dec 15, 1999
Review: 64 days
Class: Class II
Product code: ITI
Recalls: 2
Predicates: 3

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

By dateBy generation

Root · 1 generation backK900565 Invacare Power 9000 Series WheelchairInvacare Corp. · 1990
This deviceK993413 Storm Series, Power 9000 Series and Power Tiger with Gyroscope ControlInvacare Corp. · 1999
Descendant · cites it directly · 0 of its ownK042699 Ability Power GurneyGator Custom Mobility, Inc. · 2005
Descendant · cites it directly · 0 of its ownK042535 Adventure A10Ulrich Alber GmbH · 2004

Most influential descendants

Showing 2 of 2 · See all

K042699Ability Power GurneyGator Custom Mobility, Inc. · 2005 · cites it directly0descendants
K042535Adventure A10Ulrich Alber GmbH · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K900565	Invacare Power 9000 Series Wheelchair	Invacare Corp.	1990	—
0 (this device)	K993413	Storm Series, Power 9000 Series and Power Tiger with Gyroscope Control	Invacare Corp.	1999	—
+1	K042699	Ability Power Gurney	Gator Custom Mobility, Inc.	2005	—
+1	K042535	Adventure A10	Ulrich Alber GmbH	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0

FIG. 1 — Lineage of K993413, 1990–2005Source: 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
*	K940051	Action Storm Power Wheelchair Summary page 1 …cate Devices Products which are substantially equivalent to the Models Storm, Power 9000 and Power Tiger with gyroscope control are; the Invacare Storm Power wheelchair (K940051), the Invacare Power 9000 Power Wheelchair (K900565) and the Invacare Power Tiger Power Wheelchair (K930676). Intended Use The…	Invacare Corp.	1994	1
*	K900565	Invacare Power 9000 Series Wheelchair Summary page 1 …ent to the Models Storm, Power 9000 and Power Tiger with gyroscope control are; the Invacare Storm Power wheelchair (K940051), the Invacare Power 9000 Power Wheelchair (K900565) and the Invacare Power Tiger Power Wheelchair (K930676). Intended Use The intended use of the Storm Series, Power 9000 Series a…	Invacare Corp.	1990	—
*	K930676	Action Tiger Powered Wheelchair Summary page 1 …gyroscope control are; the Invacare Storm Power wheelchair (K940051), the Invacare Power 9000 Power Wheelchair (K900565) and the Invacare Power Tiger Power Wheelchair (K930676). Intended Use The intended use of the Storm Series, Power 9000 Series and Power Tiger power wheelchairs with gyroscope control…	Invacare Corp.	1994	—

Also cleared against K940051: 2 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K042699	Ability Power Gurney	Gator Custom Mobility, Inc.	2005	0
K042535	Adventure A10	Ulrich Alber GmbH	2004	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 4, 2013	Class II	Z-2270-2013	Process control	Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.
Oct 11, 2005	Not classified	Z-0303-06	Other	When the powered seating system is tilted completely in the rearward position, a potential pinch point is created between the seat and the seat frame.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K042699 (Gator Custom Mobility, Inc., 2005) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K940051.

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?

Its intended use 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/K993413 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993413: Storm Series, Power 9000 Series and Power Tiger with Gyroscope Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993413

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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