K251799 is an FDA 510(k) clearance for the Mobility Scooter (BBR-Q40-01). This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Jiangsu Bangbang Intelligent Technology Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on September 30, 2025, 110 days after receiving the submission on June 12, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K251799 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2025 |
| Decision Date | September 30, 2025 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | INI - Vehicle, Motorized 3-wheeled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3800 |