Electric Scooter (FNS01,FNS03)— 510(k) K261078
Substantially EquivalentAnhui Jbh Medical Apparatus Co., Ltd.
FDA 510(k) clearance K261078 for Electric Scooter (FNS01,FNS03), Substantially Equivalent on 2026-09-24. Applicant: Anhui Jbh Medical Apparatus Co., Ltd.. Device class: 2.
Summary
This is a pair of electric scooters, models FNS01 and FNS03, filed under INI, motorized three-wheeled vehicles. The record doesn't give specs or explain how the two models differ.
Class II, 21 CFR 890.3800. The Physical Medicine panel reviewed it as a Traditional 510(k).
Anhui Jbh Medical Apparatus Co., Ltd. filed from Chuzhou, China. Review took 176 days (April 1 to September 24, 2026).
Clearance details
- Applicant
- Anhui Jbh Medical Apparatus 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
- Chuzhou, CN
Recent devices under product code INI
view allMore clearances from Anhui Jbh Medical Apparatus Co., Ltd.
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.