# Electric Scooter (FDB08, FDB08A, FDB12) (K261859): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 30/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261859 |
| Device | Electric Scooter (FDB08, FDB08A, FDB12) |
| Applicant | Anhui JBH Medical Apparatus Co., Ltd. |
| Specialty / panel | Other |
| Product code | INI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-04 |
| Decision date | 2026-09-19 |
| Review time (days) | 107 |
| Third-party review | No |
| Applicant location | Chuzhou, CN |

## Why this score
- Fast 107-day review: this device is a strong predicate for similar products.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261859). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.