FDA product code · Physical Medicine
IORWheelchair, Mechanical
Product code IOR covers Wheelchair, Mechanical, a Class I device regulated under 21 CFR 890.3850. FDA has cleared 462 devices in this code, 16 of them in the last 12 months. Median review time across the 462 most recent decisions is 46 days. openFDA lists 40 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 890.3850
- Review panel
- Physical Medicine
- Clearances
- 462
What is happening in IOR right now?
IOR (Wheelchair, Mechanical) has three findings, most consequential first. 8 first-time filers in the last 12 months, including GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. and Rehasense USA, Inc (K261075, K260849, K260642, K254141, K260121). Clearances are running 98% slower — a median 91 days over the last 12 months against 46 days all-time (elapsed calendar days, not FDA review days) (IOR:review_time:12m). The code is crowded, scoring 100 of 100 — 259 companies hold a clearance here and 16 arrived in the last 12 months (IOR:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K261075, K260849, K260642, K254141, K260121 |
| Review time | Context | IOR:review_time:12m |
| Crowding | Context | IOR:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code IOR cover?
IOR is FDA's product code for Wheelchair, Mechanical, a Class I device regulated under 21 CFR 890.3850.
A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and/or require an assistive device for mobility.
Source: openFDA device/classification · record IOR · retrieved
How many devices has FDA cleared in IOR?
FDA has cleared 462 devices under product code IOR since the 510(k) programme began in 1976, 16 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252370 | GEN 4 JOY Wheelchair | Free Wheelchair Mission | |
| K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | |
| K261075 | Manual Wheelchair (MS01);Manual Wheelchair (MA01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | |
| K260849 | ICON 35; ICON 45; ICON 60; ICON 30FAF | Rehasense USA, Inc. | |
| K260642 | Manual Wheelchair (LW01108) | Anhui Longway Medical Technology Co., Ltd. | |
| K260295 | Helio Kids; Apex P | Motion Composites | |
| K254141 | Manual Wheelchair (DY01903(2)) | Guangdong Dayang Medical Technology Co., Ltd. | |
| K260121 | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | |
| K260319 | K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR)) | Zhenjiang Assure Medical Equipment Co., Ltd. | |
| K253632 | Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. |
How long does FDA review take for IOR?
The median FDA review time for IOR is 46 days, measured across the 462 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in IOR?
openFDA lists 40 recall records against product code IOR. A recall record covers one firm's corrective action and may span many device lots.
Z-0264-2022Open, ClassifiedTiSport, Llc
Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perform as intended if involved in a motor vehicle accident. Some affected wheelchairs can no longer be used as a passenger seat until transit tie downs are replaced with redesigned transit tie downs, verified, and released to the market.
Z-2294-2019TerminatedTiSport, Llc
The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards.
Z-2290-2016TerminatedSunrise Medical (US) LLC
There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing causing the backrest to detach from the chair frame.
Z-1025-2016TerminatedKarman Healthcare Inc
Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets.
Z-2466-2015TerminatedSunrise Medical (US) LLC
Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant.
Showing the 5 most recently initiated of 40. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for IOR?
MAUDE holds 414 adverse-event reports naming product code IOR, 42 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in IOR unusual?
Every month with enough history behind it falls inside IOR's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 28 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 61 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 13 | 2–24 | Within expected (2–24) | |
| 12 | 4–19 | Within expected (4–19) | |
| 15 | 5–21 | Within expected (5–21) | |
| 17 | 6–23 | Within expected (6–23) | |
| 19 | 6–22 | Within expected (6–22) | |
| 2 | 7–25 | Below expected (7–25) | |
| 23 | 3–34 | Within expected (3–34) | |
| 7 | 4–27 | Within expected (4–27) | |
| 1 | 0–26 | Within expected (0–26) | |
| 7 | 0–25 | Within expected (0–25) | |
| 7 | 0–22 | Within expected (0–22) | |
| 8 | 0–24 | Within expected (0–24) | |
| 2 | 0–27 | Within expected (0–27) | |
| 7 | 0–22 | Within expected (0–22) | |
| 5 | 0–24 | Within expected (0–24) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in IOR.
Who has entered IOR in the last year?
8 companies filed in IOR for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | K261075 | |
| Rehasense USA, Inc. | K260849 | |
| Anhui Longway Medical Technology Co., Ltd. | K260642 | |
| Guangdong Dayang Medical Technology Co., Ltd. | K254141 | |
| Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | K260121 | |
| Empower Ride, LLC | K251886 | |
| SUZHOU MASTER MACHINERY MANUFACTURING CO.,LTD. | K252687 | |
| Karma Mobility Co, Ltd. | K250576 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in IOR?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in IOR?
Across the 462 most recent decisions, these applicants filed most often in IOR.
| Applicant | Recent clearances |
|---|---|
| Invacare Corp. | 24 |
| Colours 'N Motion | 12 |
| Freedom Designs, Inc. | 10 |
| Everest & Jennings, Inc. | 9 |
| Invacare Corporation | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in IOR file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Invacare Corporation | 32 | 2 |
| Sunrise Medical, Inc. | 9 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch IOR
Get an email the morning anything changes in IOR — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.