IERO Mobility Scooter (IERO-01)— 510(k) K261232
Substantially EquivalentJochu Technology Co., Ltd.
FDA 510(k) clearance K261232 for IERO Mobility Scooter (IERO-01), Substantially Equivalent on 2026-07-14. Applicant: Jochu Technology Co., Ltd.. Device class: 2.
Summary
Jochu Technology's IERO Mobility Scooter (IERO-01) is filed under INI, motorized 3-wheeled vehicles. The record gives the model as IERO-01 but no specs.
Class II, 21 CFR 890.3800. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Jochu Technology filed from Hsin Chu, Taiwan. The decision came 90 calendar days after FDA received it (April 15 to July 14, 2026).
Clearance details
- Applicant
- Jochu Technology Co., Ltd.
- Product code
- Product code INI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3800
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hsin Chu, TW
Recent devices under product code INI
view allAdverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.