510(k) Report

510(k) · Cleared

Cleared

Power Drive Chair, Model: TMM6

K091043510(k) TraditionalCleared May 11, 200928-day reviewClass II21 CFR 890.3690

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Transmotion Medical, Inc. · INK Stretcher, Wheeled, Powered

Cleared on May 11, 2009 as substantially equivalent to K022309 (Stryker Corp., 2002) after a 28-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.

Decided
May 11, 2009
Review
28 days
Class
Class II
Product code
INK
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K942948 (1995). 2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2016: 1 descendant clearedK942948 · Stryker Powered Stretcher · Stryker Corp. · 1995K022309 · Stryker Powered Wheeled Stretcher · Stryker Corp. · 2002 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant K022309 · Stryker Powered Wheeled Stretcher · Stryker Corp. · 2002 · recalledK942948 · Stryker Powered Stretcher · Stryker Corp. · 19950
  1. Root · 2 generations backK942948 Stryker Powered StretcherStryker Corp. · 1995
  2. 1 generation backK022309 Stryker Powered Wheeled StretcherStryker Corp. · 2002 · Recalled
  3. This deviceK091043 Power Drive Chair, Model: TMM6Transmotion Medical, Inc. · 2009
  4. Descendant · cites it directly · 1 of its ownK110671 Winco StretchairWinco Mfg., LLC · 2011
  5. Descendant · 2 generations on · 0 of its ownK152056 Winco Model S550 StretchairWinco Manufacturing, LLC · 2016

Most influential descendants

Showing 2 of 2 · See all
  • K110671Winco StretchairWinco Mfg., LLC · 2011 · cites it directly1descendant
  • K152056Winco Model S550 StretchairWinco Manufacturing, LLC · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K942948Stryker Powered StretcherStryker Corp.1995—
−1K022309Stryker Powered Wheeled StretcherStryker Corp.20026
0 (this device)K091043Power Drive Chair, Model: TMM6Transmotion Medical, Inc.2009—
+1K110671Winco StretchairWinco Mfg., LLC2011—
+2K152056Winco Model S550 StretchairWinco Manufacturing, LLC2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201610
FIG. 1 — Lineage of K091043, 1995–2016Source: 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 INK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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
*K022309Stryker Powered Wheeled StretcherStryker Corp.20026

Also cleared against K022309: 5 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K110671Winco StretchairWinco Mfg., LLC20111

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 14 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K110671 (Winco Mfg., LLC, 2011) has gone furthest, with 1 descendant of its own.
  • 5 other devices also cite its predicate K022309.

How does its category compare?

All INK devices

INK Stretcher, Wheeled, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · INK

1in 2016

2009: 12010: 12011: 22014: 12016: 1
2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · INK

Too few INK 510(k)s in any year since 2007 to give a median.

Recalls per year · INK

7in 2011

2010: 52011: 7
2007high 7 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · INK

101in 2025

2007: 132008: 62009: 812010: 5292011: 1,5292012: 6252013: 4382014: 882015: 42016: 52017: 52018: 632019: 792020: 892021: 1142022: 932023: 1472024: 1792025: 101
2007high 1,529 (2011) · low 4 (2015)2025

MAUDE reports naming product code INK, 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
20070—013
20080—06
20091—081
20101—5529
20112—71,529
20120—0625
20130—0438
20141—088
20150—04
20161—05
20170—05
20180—063
20190—079
20200—089
20210—0114
20220—093
20230—0147
20240—0179
20250—0101
20260—0—

What is it indicated for?

The TransMotion Medical TMM6 Power Drive Chair is designed for use in short term (< 23 hours) health care facilities. Its' intended use is to provide a method of transporting patients within the facility.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K091043: Power Drive Chair, Model: TMM6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091043

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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