Submission Details
| 510(k) Number | K253075 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 23, 2025 |
| Decision Date | January 09, 2026 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
K253075 is an FDA 510(k) clearance for the Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0), a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on January 9, 2026, 108 days after receiving the submission on September 23, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K253075 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 23, 2025 |
| Decision Date | January 09, 2026 |
| Days to Decision | 108 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 |