Electric Scooter (FDB08, FDB08A, FDB12)— 510(k) K261859
Substantially EquivalentAnhui JBH Medical Apparatus Co., Ltd.
FDA 510(k) clearance K261859 for Electric Scooter (FDB08, FDB08A, FDB12), Substantially Equivalent on 2026-09-19. Applicant: Anhui JBH Medical Apparatus Co., Ltd.. Device class: 2.
Summary
Anhui JBH Medical Apparatus Co., Ltd. filed this Electric Scooter, models FDB08, FDB08A, and FDB12, under product code INI (Vehicle, Motorized 3-Wheeled). The record gives no specifications beyond the model numbers.
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). The decision was Substantially Equivalent.
The company filed from Chuzhou, China. The decision came 107 calendar days after receipt (June 4 to September 19, 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.