Suzhou Master Machinery Manufacturing Co.,Ltd · Class II · Cleared Jan 31, 2025
| K-number | K242982 |
| Device name | Mobility Scooter (MS160A) |
| Applicant | Suzhou Master Machinery Manufacturing Co.,Ltd |
| Product code | INI |
| Device class | Class II |
| Decision date | Jan 31, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 890.3800 |
The MS160A is a motorized three-wheeled mobility scooter powered by a rechargeable lithium-ion battery and DC motor. It is designed for indoor and outdoor use to provide mobility to disabled or elderly persons who are limited to a seated position. The device features a foldable frame, user-controlled speed panel, and electromagnetic braking system.
The subject device has an aluminum alloy frame, brushless 120W DC24V motor, 25.55V 10.4Ah lithium-ion battery, 7-inch front wheels and 10-inch rear wheels, maximum speed of 1.8 m/s, maximum load of 125 kg, and 8.2 km cruising range. Compared to the predicate (FDB01), it features a lighter weight (22 kg vs. 29 kg), larger rear wheels (10 vs. 8 inches), manual folding mechanism (versus one-click automatic), and different controller model. Both devices have similar frame design, seating architecture, and electromagnetic brake systems.
ISO 7176 series (static/dynamic stability, brakes, energy consumption, dimensions, speed/acceleration, seating, strength, climatic tests, obstacle-climbing, power systems), ISO 16840-10 (fire resistance), EN 12184 (electrically powered wheelchairs and scooters), IEC 60601-1-2 and IEC TR 60601-4-2 (electromagnetic compatibility), ISO 10993 series (biocompatibility including cytotoxicity, skin sensitization, and irritation).
Both devices completed performance testing per ISO 7176 standards with no safety or effectiveness concerns. The minor differences—lighter weight, larger rear wheels, manual versus automatic folding, different motor power (120W vs. 180W), battery configuration (1 pc vs. 2 pcs), and controller model—do not raise new safety issues because both devices demonstrate substantially similar functionality, intended use, control mechanisms, and structural design. The differences in performance parameters (speed, stability angles, braking distance) are within acceptable ranges when evaluated against the same consensus standards, and larger rear wheels actually improve stability rather than compromising safety.
View the full FDA submission: accessdata.fda.gov