510(k) Report

510(k) · Cleared

Cleared

Foryou Powered Wheelchair, Model FC-100

K061693510(k) TraditionalCleared Jul 6, 200621-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

Foryou Technology Co., Ltd. · ITI Wheelchair, Powered

Cleared on Jul 6, 2006 as substantially equivalent to K022697 (Teh Lin Prosthetic & Orthopaedic, Inc., 2003) after a 21-day review. Its family tree reaches back 1 generation to 2003. 12 later devices descend from it.

Decided
Jul 6, 2006
Review
21 days
Class
Class II
Product code
ITI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K022697 (2003). 12 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 4 descendants cleared2008: 1 descendant cleared2015: 2 descendants cleared2010: 1 descendant cleared2011: 1 descendant cleared2012: 1 descendant cleared2014: 2 descendants clearedK022697 · Teh Lin Jupiter Power Chair, Model TL-320 · Teh Lin Prosthetic & Orthopaedic, Inc. · 2003200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants K022697 · Teh Lin Jupiter Power Chair, Model TL-320 · Teh Lin Prosthetic & Orthopaedic, Inc. · 20030
  1. Root · 1 generation backK022697 Teh Lin Jupiter Power Chair, Model TL-320Teh Lin Prosthetic & Orthopaedic, Inc. · 2003
  2. This deviceK061693 Foryou Powered Wheelchair, Model FC-100Foryou Technology Co., Ltd. · 2006
  3. Descendant · cites it directly · 9 of its ownK070489 Heartway Power Tilt Seating System Power Chair, Model# P16RTHeartway Medical Products Co., Ltd. · 2007
  4. Descendant · 2 generations on · 5 of its ownK071006 Heartway Attendant-Controlled Power Chair, TC1Heartway Medical Products Co., Ltd. · 2007
  5. Descendant · 3 generations on · 1 of its ownK111095 Breeze Electric Transport Chair Model 1025Electro Kinetic Technologies, LLC · 2011
  6. Descendant · 3 generations on · 1 of its ownK100327 Heartway Power Chair, P23Heartway Medical Products Co., Ltd. · 2010
  7. Descendant · 2 generations on · 1 of its ownK071005 Heartway Lightweight Power Chair, P15Heartway Medical Products Co., Ltd. · 2007

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2007: 42008: 12010: 12011: 12012: 12014: 22015: 2
2007high 4 (2007) · low 0 (2009)2026

Most influential descendants

Showing 5 of 12 · See all
  • K070489Heartway Power Tilt Seating System Power Chair, Model# P16RTHeartway Medical Products Co., Ltd. · 2007 · cites it directly9descendants
  • K071006Heartway Attendant-Controlled Power Chair, TC1Heartway Medical Products Co., Ltd. · 2007 · 2 generations on5descendants
  • K111095Breeze Electric Transport Chair Model 1025Electro Kinetic Technologies, LLC · 2011 · 3 generations on1descendant
  • K100327Heartway Power Chair, P23Heartway Medical Products Co., Ltd. · 2010 · 3 generations on1descendant
  • K071005Heartway Lightweight Power Chair, P15Heartway Medical Products Co., Ltd. · 2007 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K022697Teh Lin Jupiter Power Chair, Model TL-320Teh Lin Prosthetic & Orthopaedic, Inc.2003—
0 (this device)K061693Foryou Powered Wheelchair, Model FC-100Foryou Technology Co., Ltd.2006—
+1K070489Heartway Power Tilt Seating System Power Chair, Model# P16RTHeartway Medical Products Co., Ltd.2007—
+2K071006Heartway Attendant-Controlled Power Chair, TC1Heartway Medical Products Co., Ltd.2007—
+3K111095Breeze Electric Transport Chair Model 1025Electro Kinetic Technologies, LLC2011—
+3K100327Heartway Power Chair, P23Heartway Medical Products Co., Ltd.2010—
+2K071005Heartway Lightweight Power Chair, P15Heartway Medical Products Co., Ltd.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200740
200810
201010
201110
201210
201420
201520
FIG. 1 — Lineage of K061693, 2003–2015Source: 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 510(k) statement (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
*K022697Teh Lin Jupiter Power Chair, Model TL-320
Summary page 1
…chargers - requirements and test methods) Legally marketed device for substantial equivalence comparison: TEH- LIN JUPITER Powered Wheelchair TL-320 (K022697) NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN) TEL: 886-3-53…
Teh Lin Prosthetic & Orthopaedic, Inc.2003—

Also cleared against K022697: 3 other devices →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K070489Heartway Power Tilt Seating System Power Chair, Model# P16RTHeartway Medical Products Co., Ltd.20079
K070350P&F Power Wheelchair, HC-510P & F Brother Ind., Corp.20071

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, K070489 (Heartway Medical Products Co., Ltd., 2007) has gone furthest, with 9 descendants of its own.
  • 3 other devices also cite its predicate K022697.

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—

What is it indicated for?

The device is intended for medical purposes to provide mobility to persons restricted to a sittin' position.

Indications for use as stated in the FDA 510(k) statement.

Also cleared against K022697

3 other devices cite the same predicate.

  • K050010Wu's Powered Wheelchair, Mambo 36XWu'S Tech Co., Ltd. · 2005
  • K042749Genemax Power Wheelchair, PW4Genemax Medical Products Industry Corp. · 2004
  • K042748Genemax Power Wheelchair, PW3Genemax Medical Products Industry Corp. · 2004

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/K061693 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061693: Foryou Powered Wheelchair, Model FC-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061693

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