510(k) K261232
K261232 is an FDA 510(k) premarket notification submitted by Jochu Technology Co., Ltd. for the device "IERO Mobility Scooter (IERO-01)". The FDA issued a decision of Substantially Equivalent on July 14, 2026. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 2026
- Date Received
- April 15, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vehicle, Motorized 3-Wheeled
- Device Class
- Class II
- Regulation Number
- 890.3800
- Review Panel
- PM
- Submission Type