K222711 is an FDA 510(k) clearance for the HS186B Scooter. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Suzhou Master Machinery Manufacturing Co.,Ltd (Kunshan City, CN). The FDA issued a Cleared decision on January 9, 2023, 123 days after receiving the submission on September 8, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K222711 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2022 |
| Decision Date | January 09, 2023 |
| Days to Decision | 123 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 |