FDA product code · Physical Medicine
ITIWheelchair, Powered
Product code ITI covers Wheelchair, Powered, a Class II device regulated under 21 CFR 890.3860. FDA has cleared 585 devices in this code, 34 of them in the last 12 months. Median review time across the 585 most recent decisions is 86 days. openFDA lists 71 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 890.3860
- Review panel
- Physical Medicine
- Clearances
- 585
What is happening in ITI right now?
ITI (Wheelchair, Powered) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Z-2841-2026, Z-2842-2026, Z-2843-2026, Z-2844-2026, Z-2845-2026). 21 first-time filers in the last 12 months, including Zhejiang Lumbre Electric Appliance Co., Ltd. and Ningbo Resshidi Medical Devices Co., Ltd (K261149, K261396, K261164, K260937, K260335). Clearances are running 22% slower — a median 105 days over the last 12 months against 86 days all-time (elapsed calendar days, not FDA review days) (ITI:review_time:12m). The code is crowded, scoring 100 of 100 — 255 companies hold a clearance here and 34 arrived in the last 12 months (ITI:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Serious | Z-2841-2026, Z-2842-2026, Z-2843-2026, Z-2844-2026, Z-2845-2026 |
| New entrant | Worth knowing | K261149, K261396, K261164, K260937, K260335 |
| Review time | Context | ITI:review_time:12m |
| Crowding | Context | ITI: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 ITI cover?
ITI is FDA's product code for Wheelchair, Powered, a Class II device regulated under 21 CFR 890.3860.
A powered wheelchair is a battery-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 require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).
Source: openFDA device/classification · record ITI · retrieved
How many devices has FDA cleared in ITI?
FDA has cleared 585 devices under product code ITI since the 510(k) programme began in 1976, 34 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261149 | Electric Wheelchair (DY611A-2, DY612A-1) | Zhejiang Lumbre Electric Appliance Co., Ltd. | |
| K261396 | Electric Wheelchair | Ningbo Resshidi Medical Devices Co., Ltd. | |
| K261164 | Electric wheelchair (XW-LY007 ) | Yongkang Ruihe Metal Product Co., Ltd. | |
| K260937 | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) | Shanghai Waylong Intelligent Technology Co.,Ltd | |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | |
| K260335 | Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | |
| K261175 | WHILL (WHILL Model C2) | Whill, Inc. | |
| K260056 | Power Wheelchair (N5515A, N5516, N5517A, N5519) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | |
| K260373 | Electric Wheelchair (DF506) | Jiangsu Yveelt Medical Equipment Co., Ltd. | |
| K253241 | Electric Wheelchair (Y207BL) | Jiangsu Intco Medical Products Co., Ltd. |
How long does FDA review take for ITI?
The median FDA review time for ITI is 86 days, measured across the 585 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 ITI?
openFDA lists 71 recall records against product code ITI. A recall record covers one firm's corrective action and may span many device lots.
Z-2841-2026Open, ClassifiedPride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
Z-2842-2026Open, ClassifiedPride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
Z-2843-2026Open, ClassifiedPride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
Z-2844-2026Open, ClassifiedPride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
Z-2845-2026Open, ClassifiedPride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
Showing the 5 most recently initiated of 71. 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 ITI?
MAUDE holds 1,340 adverse-event reports naming product code ITI, 754 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 ITI unusual?
5 months sit above ITI's own expected range: 1 January 2025, 1 February 2025, 1 November 2025, 1 December 2025, 1 January 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 8 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 34 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 45 | Insufficient history | No expected range — too little history | |
| 24 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 21 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 39 | 6–18 | Above expected (6–18) | |
| 36 | 3–32 | Above expected (3–32) | |
| 39 | 3–48 | Within expected (3–48) | |
| 28 | 4–58 | Within expected (4–58) | |
| 25 | 3–53 | Within expected (3–53) | |
| 43 | 3–53 | Within expected (3–53) | |
| 31 | 8–94 | Within expected (8–94) | |
| 38 | 3–65 | Within expected (3–65) | |
| 20 | 6–68 | Within expected (6–68) | |
| 14 | 2–62 | Within expected (2–62) | |
| 151 | 0–52 | Above expected (0–52) | |
| 168 | 0–150 | Above expected (0–150) | |
| 331 | 0–236 | Above expected (0–236) | |
| 24 | 0–316 | Within expected (0–316) | |
| 18 | 0–307 | Within expected (0–307) |
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 ITI.
Who has entered ITI in the last year?
8 companies filed in ITI for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Zhejiang Lumbre Electric Appliance Co., Ltd. | K261149 | |
| Ningbo Resshidi Medical Devices Co., Ltd. | K261396 | |
| Yongkang Ruihe Metal Product Co., Ltd. | K261164 | |
| Shanghai Waylong Intelligent Technology Co.,Ltd | K260937 | |
| Zhongshan Sulenz Intelligent Technology Co., Ltd. | K260335 | |
| Jiangsu Yveelt Medical Equipment Co., Ltd. | K260373 | |
| Beijing OrionStar Technology Co., Ltd. | K253952 | |
| Zhongshan A&J Medical Equipment Co., Ltd. | K253340 |
"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 ITI?
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 ITI?
Across the 585 most recent decisions, these applicants filed most often in ITI.
| Applicant | Recent clearances |
|---|---|
| Invacare Corp. | 32 |
| Fortress Scientific , Ltd. | 19 |
| Everest & Jennings, Inc. | 17 |
| Hoveround Corp. | 15 |
| Permobil AB | 11 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in ITI files 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 | 38 | 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
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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.