510(k) Report

510(k) · Cleared

Cleared

Dane Technologies Wheelchair Mover, Model WM 2000

K073701510(k) TraditionalCleared Jan 28, 200828-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

Dane Technologies · ITI Wheelchair, Powered

Cleared on Jan 28, 2008 as substantially equivalent to K023589 (Invacare Corp., 2002) after a 28-day review. Its family tree reaches back 5 generations to 1990. 1 later device descends from it.

Decided
Jan 28, 2008
Review
28 days
Class
Class II
Product code
ITI
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K900565 (1990). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

  1. Root · 5 generations backK900565 Invacare Power 9000 Series WheelchairInvacare Corp. · 1990
  2. 4 generations backK982064 Action Storm Ranger II, Action Storm Power 9000Invacare Corp. · 1998
  3. 3 generations backK991168 Arrow FWD Power WheelchairInvacare Corp. · 1999 · Recalled
  4. 2 generations backK012909 Xterra GT Power WheelchairInvacare Corp. · 2001
  5. 1 generation backK023589 Storm TDX Power WheelchairInvacare Corp. · 2002 · Recalled
  6. This deviceK073701 Dane Technologies Wheelchair Mover, Model WM 2000Dane Technologies · 2008
  7. Descendant · cites it directly · 0 of its ownK111278 Z10 Wheelchair Push and Brake Assist DeviceOtto Bock Healthcare LP · 2011

Most influential descendants

Showing 1 of 1 · See all
  • K111278Z10 Wheelchair Push and Brake Assist DeviceOtto Bock Healthcare LP · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K900565Invacare Power 9000 Series WheelchairInvacare Corp.1990—
−4K982064Action Storm Ranger II, Action Storm Power 9000Invacare Corp.1998—
−3K991168Arrow FWD Power WheelchairInvacare Corp.19992
−2K012909Xterra GT Power WheelchairInvacare Corp.2001—
−1K023589Storm TDX Power WheelchairInvacare Corp.20027
0 (this device)K073701Dane Technologies Wheelchair Mover, Model WM 2000Dane Technologies2008—
+1K111278Z10 Wheelchair Push and Brake Assist DeviceOtto Bock Healthcare LP2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
FIG. 1 — Lineage of K073701, 1990–2011Source: 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
*K023589Storm TDX Power Wheelchair
Summary page 1
…logies Wheelchair Mover Classification: Wheelchair, Powered Wheelchair - 21 CFR 890.3860 Product Code; ITI Predicate Device: Invacare, Model Storm TDX Power Wheelchair (K023589) Device Description: The Wheelchair Mover is a motorized device that attaches to, and then pushes, various types of manual wheel…
Invacare Corp.20027

Also cleared against K023589: 2 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
K111278Z10 Wheelchair Push and Brake Assist DeviceOtto Bock Healthcare LP20110

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 18 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K111278 (Otto Bock Healthcare LP, 2011) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K023589.

How does its category compare?

All ITI devices

ITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Wheelchair Mover is intended to push various types of manual wheelchairs up to 24 inches wide on dry, surfaced walkways indoors. Maximum patient plus wheelchair load capacity is 550 pounds.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K073701: Dane Technologies Wheelchair Mover, Model WM 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073701

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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