FDA product code · Physical Medicine
INIVehicle, Motorized 3-Wheeled
Product code INI covers Vehicle, Motorized 3-Wheeled, a Class II device regulated under 21 CFR 890.3800. FDA has cleared 349 devices in this code, 20 of them in the last 12 months. Median review time across the 349 most recent decisions is 76 days. openFDA lists 22 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 890.3800
- Review panel
- Physical Medicine
- Clearances
- 349
What is happening in INI right now?
INI (Vehicle, Motorized 3-Wheeled) has three findings, most consequential first. 14 first-time filers in the last 12 months, including Jochu Technology Co., Ltd. and Yongkang Ruihe Metal Product Co., Ltd (K261232, K261163, K253257, K253600, K252813). Clearances are running 42% slower — a median 108 days over the last 12 months against 76 days all-time (elapsed calendar days, not FDA review days) (INI:review_time:12m). The code is crowded, scoring 95 of 100 — 128 companies hold a clearance here and 20 arrived in the last 12 months (INI:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K261232, K261163, K253257, K253600, K252813 |
| Review time | Context | INI:review_time:12m |
| Crowding | Context | INI: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.
How many devices has FDA cleared in INI?
FDA has cleared 349 devices under product code INI since the 510(k) programme began in 1976, 20 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261232 | IERO Mobility Scooter (IERO-01) | Jochu Technology Co., Ltd. | |
| K261163 | Mobility Scooter (R200) | Yongkang Ruihe Metal Product Co., Ltd. | |
| K253257 | Virgo Mobility Scooter (Virgo-D,Virgo-F) | Jiangsu Intco Medical Products Co., Ltd. | |
| K253600 | Scooter (YD-03) | Yurob Rehabilitation Medical Co., Ltd. | |
| K260717 | Mobility Scooter (Air Carbon) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | |
| K260237 | Mobility Scooter (X-12, X-14, X-17) | Wuyi Aichi Industry and Trade Co., Ltd. | |
| K252813 | Electrical Scooter (SM4226) | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. | |
| K253936 | Power Mobility Scooter (MJMA01, MJMA02) | Nanjing Mijo Technology Co., Ltd. | |
| K253631 | Mobility Scooter (CL-Q3, CL-Q4) | Zhejiang Wei Ling New Energy Technology Co., Ltd. | |
| K253643 | Mobility Scooter (S3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. |
How long does FDA review take for INI?
The median FDA review time for INI is 76 days, measured across the 349 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 INI?
openFDA lists 22 recall records against product code INI. A recall record covers one firm's corrective action and may span many device lots.
Z-1505-2021Open, ClassifiedMerits Holdings Co. dba Merits Health Products, Inc.
Seat baseplate pin has broken in the field.
Z-1235-2014TerminatedGolden Technologies, Inc.
Buzzaround XL scooters' front to rear lockup can become unintentionally disengaged due to possible improper fit of the front alignment cup to the rear alignment screw.
Z-0115-2014TerminatedS.A.E. AFIKIM
Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it may become unresponsive during operation due to an electrical contact which may fault due to extensive wear, which potentially could result in the driver not being able to stop the scooter during operation except by turning off the ignition key.
Z-0774-2012TerminatedInvacare Corporation
Invacare Corporation decided to recall the products because the scooter backrest fails unexpectedly due to seat flexing, and this has the potential to result in a consumer falling causing death or serious injury.
Z-3211-2011TerminatedPride Mobility Products Corp.
Contract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride's Engineering drawings.
Showing the 5 most recently initiated of 22. 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 INI?
MAUDE holds 87 adverse-event reports naming product code INI, 17 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 INI unusual?
INI does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | 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 | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | 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 | |
| 3 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 4 | 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history |
31 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.
Who has entered INI in the last year?
8 companies filed in INI for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Jochu Technology Co., Ltd. | K261232 | |
| Yongkang Ruihe Metal Product Co., Ltd. | K261163 | |
| Jiangsu Intco Medical Products Co., Ltd. | K253257 | |
| Yurob Rehabilitation Medical Co., Ltd. | K253600 | |
| Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. | K252813 | |
| Nanjing Mijo Technology Co., Ltd. | K253936 | |
| Zhejiang Wei Ling New Energy Technology Co., Ltd. | K253631 | |
| Shenzhen Zhimahuaerkai Technology Co., Ltd. | K253643 |
"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 INI?
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 INI?
Across the 349 most recent decisions, these applicants filed most often in INI.
| Applicant | Recent clearances |
|---|---|
| Wu'S Tech Co., Ltd. | 16 |
| Heartway Medical Products Co., Ltd. | 15 |
| Pride Health Care, Inc. | 14 |
| C.T.M. Homecare Product, Inc. | 11 |
| Pride Mobility Products Corp. | 10 |
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 INI 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 |
|---|---|---|
| Wu'S Tech Co., Ltd. | 17 | 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 INI
Get an email the morning anything changes in INI — 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.