510(k) Report

510(k) · Cleared

Cleared

SupaChair Powered Wheelchair

K173315510(k) TraditionalCleared Feb 13, 2018117-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

Eurogreen International, Inc. · ITI Wheelchair, Powered

Cleared on Feb 13, 2018 as substantially equivalent to K073686 (C.T.M. Homecare Product, Inc., 2008) after a 117-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.

Decided
Feb 13, 2018
Review
117 days
Class
Class II
Product code
ITI
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K011153 (2001). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2021: 1 descendant clearedK011153 · Alante, Battery Operated Power Wheelchair · Golden Technologies, Inc. · 2001K073686 · C.T.M. Power Chair, Model HS-1500 · C.T.M. Homecare Product, Inc. · 2008200020052010201520202025
  1. Root · 2 generations backK011153 Alante, Battery Operated Power WheelchairGolden Technologies, Inc. · 2001
  2. 1 generation backK073686 C.T.M. Power Chair, Model HS-1500C.T.M. Homecare Product, Inc. · 2008
  3. This deviceK173315 SupaChair Powered WheelchairEurogreen International, Inc. · 2018
  4. Descendant · cites it directly · 0 of its ownK202632 Electric wheelchair (S7204/S7205)Dongguan Prestige Sporting Goods Co., Ltd. · 2021

Most influential descendants

Showing 1 of 1 · See all
  • K202632Electric wheelchair (S7204/S7205)Dongguan Prestige Sporting Goods Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K011153Alante, Battery Operated Power WheelchairGolden Technologies, Inc.2001—
−1K073686C.T.M. Power Chair, Model HS-1500C.T.M. Homecare Product, Inc.2008—
0 (this device)K173315SupaChair Powered WheelchairEurogreen International, Inc.2018—
+1K202632Electric wheelchair (S7204/S7205)Dongguan Prestige Sporting Goods Co., Ltd.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
FIG. 1 — Lineage of K173315, 2001–2021Source: 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
*K073686C.T.M. Power Chair, Model HS-1500
Summary page 8
…Per the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], we choose C.T.M. Homecare Product, Inc. Power Chair Model HS-1500 (K073686) to be our primary predicate device The reasons are C.T.M. Homecare Product, Inc. Model HS-1500 had 510k already, similar i…
C.T.M. Homecare Product, Inc.2008—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K202632Electric wheelchair (S7204/S7205)Dongguan Prestige Sporting Goods Co., Ltd.20210

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 17 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K202632 (Dongguan Prestige Sporting Goods Co., Ltd., 2021) has gone furthest, with 0 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. 2018, 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 power wheelchair intended to provide mobility to persons restricted to a sitting position

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K173315: SupaChair 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/K173315

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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