510(k) · Cleared

Recalled · 2008

JAZZY

K945936510(k) TraditionalCleared May 28, 1996540-day reviewClass II21 CFR 890.3860Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pride Health Care, Inc. · ITI Wheelchair, Powered

Cleared on May 28, 1996 after a 540-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 13 later devices descend from it. It has been recalled once.

Decided: May 28, 1996
Review: 540 days
Class: Class II
Product code: ITI
Recalls: 1
Predicates: 0

13 later devices descend from it, 8 citing it directly.

This deviceK945936 JAZZYPride Health Care, Inc. · 1996
Descendant · cites it directly · 2 of its ownK042612 JAZZY 600Pride Mobility Products Corp. · 2004 · Recalled
Descendant · cites it directly · 2 of its ownK011993 Quantum BlastPride Mobility Products Corp. · 2001 · Recalled
Descendant · cites it directly · 1 of its ownK033370 Powered Wheelchair, Model FR168WFreerider Corp · 2003
Descendant · 2 generations on · 0 of its ownK160139 Luggie ChairFreerider Corporation · 2017
Descendant · 2 generations on · 0 of its ownK143383 Q6 Edge EMPride Mobility Product Corporation · 2015 · Recalled

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1999high 3 (2003) · low 0 (2000)2026

Most influential descendants

Showing 5 of 13 · See all

K042612JAZZY 600Pride Mobility Products Corp. · 2004 · cites it directly2descendants
K011993Quantum BlastPride Mobility Products Corp. · 2001 · cites it directly2descendants
K033370Powered Wheelchair, Model FR168WFreerider Corp · 2003 · cites it directly1descendant
K160139Luggie ChairFreerider Corporation · 2017 · 2 generations on0descendants
K143383Q6 Edge EMPride Mobility Product Corporation · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K945936	JAZZY	Pride Health Care, Inc.	1996	—
+1	K042612	JAZZY 600	Pride Mobility Products Corp.	2004	4
+1	K011993	Quantum Blast	Pride Mobility Products Corp.	2001	3
+1	K033370	Powered Wheelchair, Model FR168W	Freerider Corp	2003	—
+2	K160139	Luggie Chair	Freerider Corporation	2017	—
+2	K143383	Q6 Edge EM	Pride Mobility Product Corporation	2015	7

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	2	0
2002	1	0
2003	3	0
2004	2	0
2005	1	0
2014	1	0
2015	1	0
2017	1	0

FIG. 1 — Lineage of K945936, 1996–2017Source: 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.

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?

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

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K042612	JAZZY 600	Pride Mobility Products Corp.	2004	2
K011993	Quantum Blast	Pride Mobility Products Corp.	2001	2
K033370	Powered Wheelchair, Model FR168W	Freerider Corp	2003	1
K033827	UB 140	Rivertrail Mobility	2003	0
K032879	Navigator I	Adaptive Healthcare Technologies, Inc.	2003	0
K021617	C.T.M. Power Chair, Model HS-2800	C.T.M. Homecare Product, Inc.	2002	0
K994083	Stannah Power Chair, Model 201	Stannah Power Chairs, Ltd.	2001	0
K982750	Corsaire	Optiway, Inc.	1999	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 11, 2008	Not classified	Z-1776-2008	Software design	Software - Watch dog timer feature was disabled.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K042612 (Pride Mobility Products Corp., 2004) has gone furthest, with 2 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/K945936 · printed Nov 4, 2026

Cite this page

510(k) Report. “K945936: JAZZY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945936

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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