| K-number | K242628 |
| Device name | Scooter (PS30) |
| Applicant | Lichtmega Technology Co., Ltd. |
| Product code | INI |
| Device class | Class II |
| Decision date | Dec 20, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 890.3800 |
The Scooter (PS30) is a motor-driven indoor and outdoor transportation vehicle designed to provide mobility to disabled or elderly persons who must remain seated. It features an aluminum alloy frame, four wheels, electromagnetic brake, tiller console controls, and a rechargeable lithium battery with an on-board charger.
The PS30 has minor dimensional, frame material, travel distance, turning radius, ground clearance, controller, and tire differences compared to the predicate K182471 Scooter. According to ISO 7176 series standards, these minor differences do not adversely affect safety and effectiveness or the device's intended use.
ISO 7176 series (Parts 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, 21, 22, 25), ISO 16840-10:2021, and IEC 60601-1-2:2020 for electromagnetic compatibility testing.
The proposed PS30 Scooter is substantially equivalent to predicate K182471 because both devices share identical indications for use and design intent, and the PS30's minor differences in dimensions, materials, and performance characteristics do not negatively impact safety or effectiveness. Non-clinical testing demonstrated the PS30 meets the same ISO 7176 wheelchair and scooter standards as the predicate, and compliance with these consensus standards supports equivalent safety and effectiveness.
View the full FDA submission: accessdata.fda.gov