FDA PRODUCT CODE · CLASS II
INI — Vehicle, Motorized 3-Wheeled
What these counts are not
Clearance and recall counts are SPEQ’s aggregation of FDA’s own published records for the code. A recall count is a measure of history, not of a device’s safety, neither number is an FDA rating, and SPEQ is not affiliated with the FDA.
What this classification requires
Every statement below is FDA’s own classification record for this product code, quoted from the device classification field reference. The SPEQ reading beneath each one is SPEQ’s interpretation of what it means for the work, and is not FDA text.
510(K)
SPEQ READINGA premarket notification under 21 CFR Part 807 Subpart E is the route for this code. The submission argues substantial equivalence to a legally marketed predicate, so the engineering question is which predicate the design can actually be compared against, and the evidence question is what testing supports that comparison.
Class II (moderate to high risk): general controls and special controls
SPEQ READINGSpecial controls are the distinguishing feature: performance standards, guidance documents, patient registries or postmarket surveillance named for the device type. Find the special controls before designing the test plan — they usually name the tests.
Device is eligible for The Voluntary Malfunction Summary Reporting Program
SPEQ READINGMalfunctions for this code may be reported in periodic summary form rather than as individual MDRs under 21 CFR Part 803. Eligibility is a property of the product code; using it is a decision the manufacturer makes and must be able to justify.
Not exempt due to Good Manufacturing Practice (GMP)/Quality System
SPEQ READINGThe full Quality Management System Regulation (21 CFR 820, incorporating ISO 13485:2016) applies, and is what an FDA inspection of this device will be conducted against.
Device is not implantable
SPEQ READINGNo implant-specific expectations attach from the classification itself.
Device is not used for life sustaining purposes
SPEQ READINGNo life-sustaining designation attaches to this code.
Device is a candidate for a third party review program
SPEQ READINGAn Accredited Person may conduct the 510(k) review instead of FDA. FDA still makes the clearance decision — third-party review changes who reviews, never who decides.
21 CFR 890.3800 — Motorized three-wheeled vehicle
The classification regulation for this product code, as published by the Office of the Federal Register. This is the regulation text itself — no SPEQ interpretation appears in it.
(a) Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
(b) Classification. Class II (performance standards).
Source: Electronic Code of Federal Regulations, Title 21. 21 CFR is a work of the United States Government and is in the public domain. SPEQ read this section on October 22, 2026. CFR is amended continuously, so verify against the source before acting on it: read 21 CFR 890.3800 on eCFR →
Recent clearances
Recent recalls
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 operat
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.
Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. This may result in complete failure of the seat base, causing the user to fall off the vehicle.
Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. This may result in complete failure of the seat base, causing the user to fall off the vehicle.
Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. This may result in complete failure of the seat base, causing the user to fall off the vehicle.
Seat and/or lift actuator problems: 1) Models equipped with a Seat Lift, the mast screw and washer holding the Seat Lift Actuator in place will loosen break off or fall out; 2) Models assembled with Seat Lift Actuator or Seat Post Mounting Bolts, the seat may wobble or the seat will break off from
Seat and/or lift actuator problems: 1) Models equipped with a Seat Lift, the mast screw and washer holding the Seat Lift Actuator in place will loosen break off or fall out; 2) Models assembled with Seat Lift Actuator or Seat Post Mounting Bolts, the seat may wobble or the seat will break off from t
Under conditions of heavy use, signs of overheating of the main battery cables have been observed.
Source: FDA device classification, 510(k)/PMA, and recall datasets. Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. Browse every product code SPEQ tracks →