K212090 is an FDA 510(k) clearance for the Electric Scooter. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Anhui Jbh Medical Apparatus Co., Ltd. (Chuzhou, CN). The FDA issued a Cleared decision on April 22, 2022, 290 days after receiving the submission on July 6, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K212090 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2021 |
| Decision Date | April 22, 2022 |
| Days to Decision | 290 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 |