K252502 is an FDA 510(k) clearance for the Folding Mobility Scooter (KD101). This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Nanjing Kangni Smart Technology Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on October 6, 2025, 59 days after receiving the submission on August 8, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K252502 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2025 |
| Decision Date | October 06, 2025 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | INI - Vehicle, Motorized 3-wheeled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3800 |