510(k) Report

510(k) · Cleared

Recalled · 2010

Jet 1 Powered Wheelchair

K001970510(k) TraditionalCleared Sep 26, 200090-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 Mobility Products Corp. · ITI Wheelchair, Powered

Cleared on Sep 26, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.

Decided
Sep 26, 2000
Review
90 days
Class
Class II
Product code
ITI
Recalls
1
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2012: 2 descendants cleared200020052010201520202025
  1. This deviceK001970 Jet 1 Powered WheelchairPride Mobility Products Corp. · 2000
  2. Descendant · cites it directly · 2 of its ownK092961 Jazzy FrontiePride Mobility Products Corp. · 2009
  3. Descendant · 2 generations on · 0 of its ownK113488 Jazzy Elite 6Pride Mobility Product Corporration · 2012
  4. Descendant · 2 generations on · 0 of its ownK112815 Quantum Bariatric 451Pride Mobility Product Corporration · 2012 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K092961Jazzy FrontiePride Mobility Products Corp. · 2009 · cites it directly2descendants
  • K113488Jazzy Elite 6Pride Mobility Product Corporration · 2012 · 2 generations on0descendants
  • K112815Quantum Bariatric 451Pride Mobility Product Corporration · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001970Jet 1 Powered WheelchairPride Mobility Products Corp.2000—
+1K092961Jazzy FrontiePride Mobility Products Corp.2009—
+2K113488Jazzy Elite 6Pride Mobility Product Corporration2012—
+2K112815Quantum Bariatric 451Pride Mobility Product Corporration20122

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201220
FIG. 1 — Lineage of K001970, 2000–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K092961Jazzy FrontiePride Mobility Products Corp.20092

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 1, 2010Not classifiedZ-2618-2010OtherImproper set-up of the wire harness can allow wires to be pulled from their intended position and become caught under the motor mounting bracket located under the powered wheelchair. This can cause the wire connector and/or the wire…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K092961 (Pride Mobility Products Corp., 2009) 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

2007: 182008: 92009: 72010: 62011: 42012: 62013: 52014: 52015: 102016: 62017: 42018: 42019: 32020: 62021: 132022: 162023: 82024: 382025: 292026 (partial year): 36
2007high 38 (2024) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITI

90in 2025

2007: 42 days median2008: 49 days median2009: 63 days median2010: 46 days median2011: 101 days median2012: 155 days median2013: 177 days median2014: 213 days median2015: 174 days median2016: 173 days median2017: 159 days median2018: 117 days median2019: 244 days median2020: 278 days median2021: 209 days median2022: 96 days median2023: 128 days median2024: 125 days median2025: 90 days median2026 (partial year): 108 days median
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

2007: 32008: 32009: 12010: 22012: 12016: 12017: 22021: 32024: 12025: 3, 2 Class I2026 (partial year): 13
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

2007: 1232008: 1332009: 1832010: 1572011: 5252012: 2,9192013: 8,7412014: 7,2822015: 4,6852016: 1,5752017: 3012018: 2732019: 2642020: 2052021: 1662022: 1352023: 2232024: 1462025: 647
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200718423123
20089493133
20097631183
20106462157
201141010525
2012615512,919
2013517708,741
2014521307,282
20151017404,685
2016617311,575
201741592301
201841170273
201932440264
202062780205
2021132093166
202216960135
202381280223
2024381251146
202529903 (2)647
20263610813—
Cite this page

510(k) Report. “K001970: Jet 1 Powered Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001970

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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