K250533 is an FDA 510(k) clearance for the Magnesium alloy scooter (RS100). This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Taizhou Reach Technology Co., Ltd. (Taixing City, CN). The FDA issued a Cleared decision on May 14, 2025, 79 days after receiving the submission on February 24, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K250533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2025 |
| Decision Date | May 14, 2025 |
| Days to Decision | 79 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 |