510(k) Report

510(k) · Cleared

Cleared

Electrically Powered Wheelchair, Joy Rider

K220156510(k) TraditionalCleared Oct 7, 2022261-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

Tung Keng Enterprise Co., Ltd. · ITI Wheelchair, Powered

Cleared on Oct 7, 2022 as substantially equivalent to K170787 (Nanjing Jin Bai HE Medical Apparatus Co., Ltd., 2017) after a 261-day review. Its family tree reaches back 1 generation to 2017. 1 later device descends from it.

Decided
Oct 7, 2022
Review
261 days
Class
Class II
Product code
ITI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K170787 (2017). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2026: 1 descendant clearedK170787 · Powered Wheelchair DYW30A (D09) · Nanjing Jin Bai HE Medical Apparatus Co., Ltd. · 2017201620182020202220242026
Descendants, by generation 1 generation forward: 1 descendant K170787 · Powered Wheelchair DYW30A (D09) · Nanjing Jin Bai HE Medical Apparatus Co., Ltd. · 20170
  1. Root · 1 generation backK170787 Powered Wheelchair DYW30A (D09)Nanjing Jin Bai HE Medical Apparatus Co., Ltd. · 2017
  2. This deviceK220156 Electrically Powered Wheelchair, Joy RiderTung Keng Enterprise Co., Ltd. · 2022
  3. Descendant · cites it directly · 0 of its ownK260335 Electric Wheelchair (S500-6)Zhongshan Sulenz Intelligent Technology Co., Ltd. · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K260335Electric Wheelchair (S500-6)Zhongshan Sulenz Intelligent Technology Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K170787Powered Wheelchair DYW30A (D09)Nanjing Jin Bai HE Medical Apparatus Co., Ltd.2017—
0 (this device)K220156Electrically Powered Wheelchair, Joy RiderTung Keng Enterprise Co., Ltd.2022—
+1K260335Electric Wheelchair (S500-6)Zhongshan Sulenz Intelligent Technology Co., Ltd.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K220156, 2017–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) Report

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
*K170787Powered Wheelchair DYW30A (D09)
Summary page 4
…cturer: Nanjing Jin Bai He Medical Apparatus Co., Ltd. Device name: Powered Wheelchair, DYW30A(D09) 510(k) number: K170787 Indications for Use: The device is a motor-driven, and indoor transportation vehicle with the intended use to pro…
Nanjing Jin Bai HE Medical Apparatus Co., Ltd.2017—

Also cleared against K170787: 4 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K260335Electric Wheelchair (S500-6)Zhongshan Sulenz Intelligent Technology Co., Ltd.20260

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?

  • Its one ancestor has no recall.
  • Of its descendants, K260335 (Zhongshan Sulenz Intelligent Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K170787.

How does its category compare?

All ITI devices

ITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K220156: Electrically Powered Wheelchair, Joy Rider.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220156

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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