Zhongshan A&J Medical Equipment Co., Ltd. · Class II · Cleared Apr 3, 2026
| K-number | K253340 |
| Device name | Electric Wheelchair (AL-208S-063) |
| Applicant | Zhongshan A&J Medical Equipment Co., Ltd. |
| Product code | ITI |
| Device class | Class II |
| Decision date | Apr 3, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 890.3860 |
The Electric Wheelchair (AL-208S-063) is a battery-powered, motor-driven indoor and outdoor mobility device controlled by a joystick. It is intended to provide transportation for disabled or elderly persons limited to a seated position and is suitable for users weighing less than 100 kg.
The device features a front frame, rear frame, backrest frame, armrest, front wheel, rear controller, front controller, battery pack, motor rear wheel, footplate, seat cushion, and handgrip. It operates through joystick control with adjustable speed. The technological characteristics, features, specifications, materials, mode of operation, and intended use are substantially equivalent to the predicate device.
Testing per ISO 7176 series (Parts 1–15, 21–22) covering stability, braking, energy consumption, speed, strength, climatic conditions, and seating dimensions; ISO 16840-10 for ignition resistance; IEC 60601-1-2 and ISO 7176-21 for electromagnetic compatibility; IEC 62133-2 for battery safety; and ISO 10993-1 for biocompatibility.
The subject device has the same indications for use as the predicate device (K231508, Power Wheelchair W5521). Testing shows it is as safe and effective as the predicate; the differences between the subject and predicate devices do not raise new safety or effectiveness concerns. No clinical testing was performed, relying on nonclinical bench testing per applicable standards.
View the full FDA submission: accessdata.fda.gov