DeviceClearance

Product code INI— Physical Medicine

HEARTWAY Power Mobility Scooter

Classification name
Vehicle, Motorized 3-Wheeled
Device class
Class 2
Regulation
21 CFR 890.3800
Advisory panel
Physical Medicine
Total cleared
351
First cleared
Most recent

Market context for product code INI

FDA has cleared 351 devices under product code INI between 1982 and 2026, filed by 132 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code INI

Adverse events under product code INI

product code INI
Injury
171
Other
1
Total
172

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code INI

1–100 of 351

Data sourced from openFDA. This site is unofficial and independent of the FDA.