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FDA product code IOR · class 1 · Physical Medicine

Wheelchair, mechanical: medical device reports filed with FDA

28,715 reports carry this product code, 1992–2026; 30 brands with a page.

28,715
reports with this product code
0.1% of all MAUDE reports
3,083
reports, 12 months to August 2026
174 in the 12 months before
89.3%
classified as malfunction
62.3% across all reports
0.2%
classified as death, as reported
0.9% across all reports

Product code IOR is FDA's classification for "Wheelchair, mechanical" (physical Medicine panel), a class 1 device. 28,715 medical device reports carry this product code, 0.1% of the MAUDE database, from January 1992 to August 2026.

3,083 reports arrived in the 12 months to August 2026, up 1672% from 174 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (89.3%), injury (3.7%) and other (0.5%). 30 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

BrandReportsLatest 12 monthsClassified as deathClassified as malfunction
Mechanical Manual Wheelchair10,13800%82.3%
Quickie 2 Wheelchair3,75400%99.8%
Medline2,86526,1840.1%97.9%
Transport 20 In X 16 In 91536375741,93400.1%99.1%
Quickie1,27210.2%93.6%
Solara 3g Demo 3 Low Shear Recline/20 In H Matrx Pb Back59800%100%
9xt Swingaway Frame Style 915362915336800%99.7%
Tracer Transport Chair 19 X 16 915364702933900%98.8%
Breezy Wheelchair33300%100%
Quickie Rx Wheelchair32000%99.4%
Quickie Revolution Wheelchair31100%100%
T4/Wd28/Hd/Adult/18/Bh16/At903/U2222c/U67 915365356929100%99.3%
Trsx5/Wd08/Ad/28/34p/U240/1255/U2222/Ahdrm/9691b/Gvt93hc/G1360/Bh16 915364940328000%98.9%
Trex2/Wd06/18/Bh16/U2222c/Adult/U67/1255 915365355319800%100%
Solara 3g Ltd 20w 24 Com 915365325016700%98.2%
Non-Folding Device 915364534214700%100%
Guardian1273500.4%72.2%
Rollator 91536513157500%98.5%
Powered Wheelchair6100.1%96.8%
Mechanical Chair/Transport Chair4800.2%11%
Mechanical Walker Rollator4100%10.5%
Drive39204.4%13.1%
Invacare38017%27%
Power Chair 20 Wide By 18 Deep For Pmi3000%99.4%
Drive Medical19010%5.2%
50psi Compressor Mobilaire 91536199381400%99.6%
Economy Rollator W/Hand Brake W/Curve Bkrst 91536445471300%96.4%
Envoy Aer Compressor 230v Aus 91536329531000%98.7%
Tdxsp Electric Red Euro Wide Base W/ 23-1 Ssd Gear Box1000.2%98.9%
Wheelchair Components800%75.6%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)ReportsShare
Invamex8,13628.3%
Invacare Taylor Street4,53115.8%
Sunrise Medical Mpd3,65612.7%
Medline Industries3,03810.6%
Quickie Designs2,5308.8%
Invacare3381.2%
Danyang Maxthai Medical Equipment2030.7%
Kenstone Metal370.1%
Invacare Florida Operations290.1%
Invacare Suzhou250.1%
Invacare Rehabilitation Equipment180.1%
Genteel Homecare Products150.1%
Pride Mobility Products120%
Invacare Rehabilitation Equip90%

Reports by month, five years

01,1722,344Sep 2021: 8Oct 2021: 5Nov 2021: 1Dec 2021: 32022Jan 2022: 2Feb 2022: 3Mar 2022: 2Apr 2022: 2May 2022: 2Jun 2022: 2Jul 2022: 3Aug 2022: 2Sep 2022: 4Oct 2022: 3Nov 2022: 2Dec 2022: 102023Jan 2023: 4Feb 2023: 3Mar 2023: 4Apr 2023: 2May 2023: 7Jun 2023: 28Jul 2023: 15Aug 2023: 64Sep 2023: 2Oct 2023: 19Nov 2023: 16Dec 2023: 12024Jan 2024: 1Feb 2024: 6Mar 2024: 14Apr 2024: 13May 2024: 9Jun 2024: 4Jul 2024: 12Aug 2024: 20Sep 2024: 8Oct 2024: 17Nov 2024: 20Dec 2024: 142025Jan 2025: 14Feb 2025: 17Mar 2025: 16Apr 2025: 17May 2025: 19Jun 2025: 2Jul 2025: 23Aug 2025: 7Sep 2025: 1Oct 2025: 7Nov 2025: 7Dec 2025: 82026Jan 2026: 2Feb 2026: 7Mar 2026: 5Apr 2026: 12May 2026: 115Jun 2026: 80Jul 2026: 495Aug 2026: 2,344

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.2%55
Injury3.7%1,065
Malfunction89.3%25,647
Other0.5%153
Not given6.3%1,795

Who filed

Manufacturer report96%27,553
Voluntary report1.1%329
User facility report0%0
Distributor report2.3%669
Not given0.6%164

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)ReportsShare
Breakthe device broke8,59329.9%
Component(s), broken2,5158.8%
Bent1,8976.6%
Fracturea broken bone1,4895.2%
Device operates differently than expectedthe device behaved unexpectedly1,3524.7%
Detachment of device component1,3044.5%
Crackthe device cracked1,1864.1%
Mechanical problema mechanical problem1,1263.9%
Device slipped8372.9%
Unstable6142.1%
Detachment of device or device componentpart of the device came off5812%
Material twisted/bent4791.7%
Torn material4391.5%
Naturally worn4351.5%
Loose or intermittent connection3921.4%
Component falling3711.3%
Component missing3671.3%
Activation problem3311.2%
Material separation3151.1%
Product quality problem3121.1%

Questions about wheelchair, mechanical reports

What is product code IOR?

FDA's classification code for "Wheelchair, mechanical", class 1, reviewed by the physical Medicine panel. Every device report carries the product code of the device involved.

How many reports carry this code?

28,715 reports through August 2026, 3,083 of them in the latest 12 months.

Which brands appear most often?

Mechanical Manual Wheelchair (10,138), Quickie 2 Wheelchair (3,754), Medline (2,865), Transport 20 In X 16 In 9153637574 (1,934) and Quickie (1,272). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.