510(k) Report

510(k) · Cleared

Cleared

Power Wheelchair

K113463510(k) TraditionalCleared Apr 6, 2012136-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

Suzhou KD Medical Appliance Co., Ltd. · ITI Wheelchair, Powered

Cleared on Apr 6, 2012 as substantially equivalent to K070501 (Shanghai Ruike Sports Goods Co., Ltd., 2007) after a 136-day review. Its family tree reaches back 3 generations to 2003. 71 later devices descend from it.

Decided
Apr 6, 2012
Review
136 days
Class
Class II
Product code
ITI
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K023148 (2003). 71 later devices descend from it, 13 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2024: 24 descendants cleared2025: 20 descendants cleared2022: 6 descendants cleared2023: 4 descendants cleared2021: 1 descendant cleared2026: 14 descendants cleared2020: 1 descendant clearedK023148 · Epw Powered Wheelchair, GP-201 · Emg Technology Co., Ltd. · 2003K062888 · Middle Wheel Drive Power Chair, CWD01 · Emg Technology Co., Ltd. · 2006K070501 · Ruike 3421 Powered Wheelchair · Shanghai Ruike Sports Goods Co., Ltd. · 2007200020052010201520202025
Descendants, by generation 1 generation forward: 13 descendants2 generations forward: 30 descendants3 generations forward: 22 descendants4 generations forward: 6 descendants K070501 · Ruike 3421 Powered Wheelchair · Shanghai Ruike Sports Goods Co., Ltd. · 2007K062888 · Middle Wheel Drive Power Chair, CWD01 · Emg Technology Co., Ltd. · 2006K023148 · Epw Powered Wheelchair, GP-201 · Emg Technology Co., Ltd. · 20030
  1. Root · 3 generations backK023148 Epw Powered Wheelchair, GP-201Emg Technology Co., Ltd. · 2003
  2. 2 generations backK062888 Middle Wheel Drive Power Chair, CWD01Emg Technology Co., Ltd. · 2006
  3. 1 generation backK070501 Ruike 3421 Powered WheelchairShanghai Ruike Sports Goods Co., Ltd. · 2007
  4. This deviceK113463 Power WheelchairSuzhou KD Medical Appliance Co., Ltd. · 2012
  5. Descendant · cites it directly · 37 of its ownK220747 Power Wheelchair (N5515B)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022
  6. Descendant · 2 generations on · 8 of its ownK231508 Power Wheelchair, W5521Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
  7. Descendant · 2 generations on · 7 of its ownK230964 Power Wheelchair (N5909)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
  8. Descendant · cites it directly · 7 of its ownK163204 A08 Power wheelchairKunshan Aoshida Electric Technology Co., Ltd. · 2017
  9. Descendant · 2 generations on · 6 of its ownK240913 Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd · 2024

Showing 5 of 71 descendants. See all descendants

Descendants cleared per year

2017: 12020: 12021: 12022: 62023: 42024: 242025: 202026: 14
2017high 24 (2024) · low 0 (2018)2026

Most influential descendants

Showing 5 of 71 · See all
  • K220747Power Wheelchair (N5515B)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022 · cites it directly37descendants
  • K231508Power Wheelchair, W5521Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023 · 2 generations on8descendants
  • K230964Power Wheelchair (N5909)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023 · 2 generations on7descendants
  • K163204A08 Power wheelchairKunshan Aoshida Electric Technology Co., Ltd. · 2017 · cites it directly7descendants
  • K240913Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd · 2024 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K023148Epw Powered Wheelchair, GP-201Emg Technology Co., Ltd.2003—
−2K062888Middle Wheel Drive Power Chair, CWD01Emg Technology Co., Ltd.2006—
−1K070501Ruike 3421 Powered WheelchairShanghai Ruike Sports Goods Co., Ltd.2007—
0 (this device)K113463Power WheelchairSuzhou KD Medical Appliance Co., Ltd.2012—
+1K220747Power Wheelchair (N5515B)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd2022—
+2K231508Power Wheelchair, W5521Zhejiang Innuovo Rehabilitation Devices Co.,Ltd2023—
+2K230964Power Wheelchair (N5909)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd2023—
+1K163204A08 Power wheelchairKunshan Aoshida Electric Technology Co., Ltd.2017—
+2K240913Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202010
202110
202260
202340
2024240
2025200
2026140
FIG. 1 — Lineage of K113463, 2003–2026Source: 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), 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. #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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K070501Ruike 3421 Powered Wheelchair
Summary page 1
…ecialty (Panel): Physical Medicine Device Regulation number: 890.3860 Product Code: ITI Classification: Class 11 Predicate devices Ruike 3421 (K070501) / Shanghai Ruike Sports Goods CO., LTD Intend use of device The device is a motor driven, indoor and outdoor transport…
Shanghai Ruike Sports Goods Co., Ltd.2007—

Also cleared against K070501: 1 other device →

What descends from it? (71)

See all 71

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

NumberDeviceApplicantDecidedDescendants
K220747Power Wheelchair (N5515B)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd202237
K163204A08 Power wheelchairKunshan Aoshida Electric Technology Co., Ltd.20177
K232193Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)Yurob Rehabilitation Medical Co., Ltd.20235
K212092Portable Folding Electric Wheelchair (Model: DC01)Anhui Jbh Medical Apparatus Co., Ltd.20225
K202482Y207 Electric WheelchairJiangsu Intco Medical Products Co., Ltd.20215
K250158Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003)Zhe Jiang Cleisman Industry and Trade Co.,Ltd20252
K262241Electric Wheelchair (0080)Xuzhou Heabens Medical Technology Co., Ltd.20260
K260373Electric Wheelchair (DF506)Jiangsu Yveelt Medical Equipment Co., Ltd.20260
K252829Powered Wheelchair (PL001-9001)Suzhou KD Intelligent Device Co., Ltd.20250
K251248Electric Wheelchair (QDWP-A01,QDWP-B02)Jinhua Qidian Vehicle Co., Ltd.20250

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K220747 (Zhejiang Innuovo Rehabilitation Devices Co.,Ltd, 2022) has gone furthest, with 37 descendants of its own.
  • 1 other device also cites its predicate K070501.

How does its category compare?

All ITI devices

ITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

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—

What is it indicated for?

The device is a motor driven. indoor and outdoor transportation vehicle with the intended use to Provide mobility to a disabled or elderly person limited to a seated position.

Indications for use as stated in the FDA summary.

Also cleared against K070501

1 other device cites the same predicate.

  • K110036FX 222-02 Powered WheelchairLanzhou Wanli Aviation Electromechanical, Inc. · 2011

Recent decisions in ITI

The ITI category page

  • K261169Power Wheelchair (D39)Anhui JBH Medical Apparatus Co., Ltd. · 2026
  • K263257Electrically Powered Wheelchair (YC-01)Yurob Rehabilitation Medical Co., Ltd. · 2026
  • K262652Electric Wheelchair (CN501)Zhejiang Shimo Technology Co., Ltd. · 2026
  • K261079Power Wheelchair (DC12)Anhui JBH Medical Apparatus Co., Ltd. · 2026
  • K261200Power Wheelchair (D60)Anhui JBH Medical Apparatus Co., Ltd. · 2026

https://510kreport.com/device/K113463 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113463: Power Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113463

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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