K201196 is an FDA 510(k) clearance for the Scooter (Model: FDB01). This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Nanjing Jin Bai HE Medical Apparatus Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on June 25, 2021, 417 days after receiving the submission on May 4, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K201196 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2020 |
| Decision Date | June 25, 2021 |
| Days to Decision | 417 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 |