510(k) Report

510(k) · Cleared

Cleared

Middle Wheel Drive Power Chair, CWD01

K062888510(k) TraditionalCleared Oct 24, 200628-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

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

Cleared on Oct 24, 2006 as substantially equivalent to K023148 (Emg Technology Co., Ltd., 2003) after a 28-day review. Its family tree reaches back 1 generation to 2003. 78 later devices descend from it.

Decided
Oct 24, 2006
Review
28 days
Class
Class II
Product code
ITI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K023148 (2003). 78 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2007: 3 descendants cleared2008: 1 descendant cleared2011: 1 descendant cleared2012: 1 descendant cleared2017: 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. · 2003200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 2 descendants3 generations forward: 13 descendants4 generations forward: 30 descendants5 generations forward: 22 descendants6 generations forward: 6 descendants K023148 · Epw Powered Wheelchair, GP-201 · Emg Technology Co., Ltd. · 20030+5
  1. Root · 1 generation backK023148 Epw Powered Wheelchair, GP-201Emg Technology Co., Ltd. · 2003
  2. This deviceK062888 Middle Wheel Drive Power Chair, CWD01Emg Technology Co., Ltd. · 2006
  3. Descendant · cites it directly · 73 of its ownK070501 Ruike 3421 Powered WheelchairShanghai Ruike Sports Goods Co., Ltd. · 2007
  4. Descendant · 2 generations on · 71 of its ownK113463 Power WheelchairSuzhou KD Medical Appliance Co., Ltd. · 2012
  5. Descendant · 3 generations on · 37 of its ownK220747 Power Wheelchair (N5515B)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022
  6. Descendant · 4 generations on · 8 of its ownK231508 Power Wheelchair, W5521Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
  7. Descendant · 4 generations on · 7 of its ownK230964 Power Wheelchair (N5909)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023

Showing 5 of 78 descendants. See all descendants

Descendants cleared per year

2007: 32008: 12010: 12011: 12012: 12017: 12020: 12021: 12022: 62023: 42024: 242025: 202026: 14
2007high 24 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 78 · See all
  • K070501Ruike 3421 Powered WheelchairShanghai Ruike Sports Goods Co., Ltd. · 2007 · cites it directly73descendants
  • K113463Power WheelchairSuzhou KD Medical Appliance Co., Ltd. · 2012 · 2 generations on71descendants
  • K220747Power Wheelchair (N5515B)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022 · 3 generations on37descendants
  • K231508Power Wheelchair, W5521Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023 · 4 generations on8descendants
  • K230964Power Wheelchair (N5909)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023 · 4 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K023148Epw Powered Wheelchair, GP-201Emg Technology Co., Ltd.2003—
0 (this device)K062888Middle Wheel Drive Power Chair, CWD01Emg Technology Co., Ltd.2006—
+1K070501Ruike 3421 Powered WheelchairShanghai Ruike Sports Goods Co., Ltd.2007—
+2K113463Power WheelchairSuzhou KD Medical Appliance Co., Ltd.2012—
+3K220747Power Wheelchair (N5515B)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd2022—
+4K231508Power Wheelchair, W5521Zhejiang Innuovo Rehabilitation Devices Co.,Ltd2023—
+4K230964Power Wheelchair (N5909)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200730
200810
201010
201110
201210
201710
202010
202110
202260
202340
2024240
2025200
2026140
FIG. 1 — Lineage of K062888, 2003–2026Source: 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
*K023148Epw Powered Wheelchair, GP-201
Summary page 1
…, and their chargers - requirements and test methods) Legally marketed device for substantial equivalence comparison: EPW POWERED WHEELCHAIR GP-201 ( K023148) EMG TECHNOLOGY CO., LTD.…
Emg Technology Co., Ltd.2003—

Also cleared against K023148: 1 other device →

What descends from it? (78)

See all 78

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

NumberDeviceApplicantDecidedDescendants
K070501Ruike 3421 Powered WheelchairShanghai Ruike Sports Goods Co., Ltd.200773
K072224Zip'r PCGlobal Fabtech Wheelchair (Shanghai) Co., Ltd.20071
K072027Foru KV10HBKwang Yang Motor Co., Ltd.20071
K102355Zip'r Mantis Powered WheelchairGlobal Fabtech Wheelchair (Shanghai) Co., Ltd.20100
K082288Haida HD21Jiangyin East China Medical Technology Co., Ltd.20080

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, K070501 (Shanghai Ruike Sports Goods Co., Ltd., 2007) has gone furthest, with 73 descendants of its own.
  • 1 other device also cites its predicate K023148.

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 sitting position.

Indications for use as stated in the FDA summary.

Also cleared against K023148

1 other device cites the same predicate.

  • K040320Sinon Power Wheelchair, SN-P401Sinon Corporation · 2004

More from Emg Technology Co., Ltd.

11 FDA decisions under this applicant name. See the company

  • K112421Emg Suction UnitEmg Technology Co., Ltd. · 2011
  • K072634Emg Triton -Comp,Model NCA01-XXX SeriesEmg Technology Co., Ltd. · 2008
  • K063448Emg AC/DC Suction UnitEmg Technology Co., Ltd. · 2006
  • K052438Emg Handle Nebulizer NB02 SeriesEmg Technology Co., Ltd. · 2006
  • K043520Emg CTA01-XXX Series Puro Oxygen ConcentratorEmg Technology Co., Ltd. · 20052 recalls

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/K062888 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062888: Middle Wheel Drive Power Chair, CWD01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062888

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