510(k) Report

510(k) · Cleared

Cleared

Compact Wheelchair Platform

K101723510(k) TraditionalCleared Dec 23, 2010188-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 Fletcher · INO Chair, Positioning, Electric

Cleared on Dec 23, 2010 as substantially equivalent to K073565 (Design Specific, Ltd., 2009) after a 188-day review. Its family tree reaches back 4 generations to 1989.

Decided
Dec 23, 2010
Review
188 days
Class
Class II
Product code
INO
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K885343 (1989). 6 ancestors in all. No later device cites it as a predicate yet.

  1. Root · 4 generations backK885343 StandexAlt, Inc. · 1989
  2. 3 generations backK062402 Easystand EvolvInvacare Corp. · 2006
  3. 2 generations backK071793 Convertible I-Series Positioning and Transfer ChairBarton Medical Corp. · 2007
  4. 1 generation backK073565 Standard Wheelchair PlatformDesign Specific, Ltd. · 2009
  5. This deviceK101723 Compact Wheelchair PlatformDesign Specific Fletcher · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K885343StandexAlt, Inc.1989—
−3K062402Easystand EvolvInvacare Corp.2006—
−2K071793Convertible I-Series Positioning and Transfer ChairBarton Medical Corp.2007—
−1K073565Standard Wheelchair PlatformDesign Specific, Ltd.2009—
0 (this device)K101723Compact Wheelchair PlatformDesign Specific Fletcher2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
FIG. 1 — Lineage of K101723, 1989–2010Source: 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 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
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
*K073565Standard Wheelchair Platform
Summary page 2
…Dental Chair and Accessories (CFR 890,3110 Class II) Equivalence Mobile wheelchair Platform Design Specific Ltd K073565 Description The Compact Wheelchair Platform (CWP) is designed to assist in the clinical treat…
Design Specific, Ltd.2009—

What descends from it?

No later submission names this one as a predicate yet.

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 21 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
  • None of the 6 ancestors has a recall.

How does its category compare?

All INO devices

INO Chair, Positioning, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?

The Clinicsl treatment of pemsns in wheelchairs presents a significant issue for clinicians and patients alike. Procedures related to a patient's head often require them to be reclined. A platform for reclining the wheelchair giving flil support to both chair and patient provides a safer working environment for both patient and clinician. The hazar-ds associated with transfers to other couches or chairs are elimiated.

Typical treatments would include:

*Dental

*Maxiliofacial work

*Ear, Nose and Throat procedures

*Eye treatments and surgery

* Podiatry

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K101723: Compact Wheelchair Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101723

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