510(k) Report

510(k) · Cleared

Cleared

Standard Wheelchair Platform

K073565510(k) TraditionalCleared Feb 6, 2009415-day reviewClass II21 CFR 890.3110

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

Design Specific, Ltd. · INO Chair, Positioning, Electric

Cleared on Feb 6, 2009 as substantially equivalent to K071793 (Barton Medical Corp., 2007) and 1 other predicate after a 415-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.

Decided
Feb 6, 2009
Review
415 days
Class
Class II
Product code
INO
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K885343 (1989). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors2010: 1 descendant clearedK885343 · Standex · Alt, Inc. · 1989K062402 · Easystand Evolv · Invacare Corp. · 2006K071793 · Convertible I-Series Positioning and Transfer Chair · Barton Medical Corp. · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 1 descendant K071793 · Convertible I-Series Positioning and Transfer Chair · Barton Medical Corp. · 2007K062402 · Easystand Evolv · Invacare Corp. · 2006K885343 · Standex · Alt, Inc. · 19890
  1. Root · 3 generations backK885343 StandexAlt, Inc. · 1989
  2. 2 generations backK062402 Easystand EvolvInvacare Corp. · 2006
  3. 1 generation backK071793 Convertible I-Series Positioning and Transfer ChairBarton Medical Corp. · 2007
  4. This deviceK073565 Standard Wheelchair PlatformDesign Specific, Ltd. · 2009
  5. Descendant · cites it directly · 0 of its ownK101723 Compact Wheelchair PlatformDesign Specific Fletcher · 2010

Most influential descendants

Showing 1 of 1 · See all
  • K101723Compact Wheelchair PlatformDesign Specific Fletcher · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K885343StandexAlt, Inc.1989—
−2K062402Easystand EvolvInvacare Corp.2006—
−1K071793Convertible I-Series Positioning and Transfer ChairBarton Medical Corp.2007—
0 (this device)K073565Standard Wheelchair PlatformDesign Specific, Ltd.2009—
+1K101723Compact Wheelchair PlatformDesign Specific Fletcher2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K073565, 1989–2010Source: 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 INO? 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? (4)

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
*K071793Convertible I-Series Positioning and Transfer Chair
Summary page 2
…Barton Medical Corp. 5725 Hway 290 West #103 Austin TX 78735 8701 5 10(k) No. K071793 Electronic Positioning Chair Medline Industries Inc One Med…
Barton Medical Corp.2007—
*K001937Medline Electronic Positioning Chair
Summary page 2
…sitioning Chair Medline Industries Inc One Medline Place JL 60060 5 10(k) No. K001937 Dental Tilting Ramp TRICO Metal Products Wyandotte Rd,…
Medline Industries, Inc.2000—
*—Dental Tilting Ramp
Named without a submission number
—
*—Rehabilitation Hospital Philadelphia
Named without a submission number
—

Also cleared against K071793: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K101723Compact Wheelchair PlatformDesign Specific Fletcher20100

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 20 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K101723 (Design Specific Fletcher, 2010) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K071793.

How does its category compare?

All INO devices

INO Chair, Positioning, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · INO

1in 2014

2007: 22008: 22009: 42010: 12011: 12013: 12014: 1
2007high 4 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · INO

126in 2009

2009: 126 days median
2007high 126 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · INO

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

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

Adverse event reports per year · INO

29in 2025

2007: 12008: 52009: 62010: 72011: 202012: 152013: 242014: 162015: 232016: 352017: 382018: 382019: 372020: 412021: 492022: 292023: 292024: 202025: 29
2007high 49 (2021) · low 1 (2007)2025

MAUDE reports naming product code INO, 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
20072—01
20082—05
2009412606
20101—07
20111—020
20120—015
20131—024
20141—016
20150—023
20160—035
20170—038
20180—038
20190—037
20200—041
20210—049
20220—129
20230—029
20240—020
20250—029
20260—0—

What is it indicated for?

Patients in wheelchairs present problems to clinicians who need to treat them and the patients themselves can be seriously disadvantaged by their situation. This is particularly true of dental treatment. To be treated the dentist would need to bend around the patient in the wheelchair, that cusses back pain and sometimes injury. An alternate approach is to transfer the patient to a conventional chair by slings and hoists or other approaches, all of which…

Read the full statement (139 words)

Patients in wheelchairs present problems to clinicians who need to treat them and the patients themselves can be seriously disadvantaged by their situation. This is particularly true of dental treatment. To be treated the dentist would need to bend around the patient in the wheelchair, that cusses back pain and sometimes injury. An alternate approach is to transfer the patient to a conventional chair by slings and hoists or other approaches, all of which hold significant health and safety risks.

The wheelchair platform offers a safe environment for both clinician and patient. The wheelchair is moved onto the platform up against a back wall support and the wheelchair and patient are then supported by a backrest and a head support. The platform is reclined, and possibly raised and lowered, to present the patient in the best position for treatment.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K073565: Standard Wheelchair Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073565

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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