| K-number | K252101 |
| Device name | JWG-1 |
| Applicant | Yamaha Motor Co., Ltd. |
| Product code | ITI |
| Device class | Class II |
| Decision date | Mar 19, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 890.3860 |
The JWG-1 is a powered wheelchair conversion kit that transforms a manually propelled wheelchair into a powered wheelchair. It consists of left/right drive units, a controller, battery (Yamaha Li-ion JWB3), and charger (JWC4), with the drive units replacing the original wheels to enable disabled persons to self-propel and increase mobility.
The device has the same intended use and similar technological characteristics as the predicate devices (JWX-1 PLUS and e-fix E35/E36). It is a Class II powered wheelchair with product code ITI, regulated under 21 CFR 890.3860, and does not raise new questions of safety or effectiveness.
ISO 7176 series (Parts 1, 2, 3, 4, 6, 8, 9, 11, 14, 15, 21) for wheelchair stability, dynamics, brakes, energy consumption, speed, strength, climatic conditions, and electromagnetic compatibility; ISO 10993 series (Parts 1, 5, 10) for biological evaluation and biocompatibility.
The JWG-1 is substantially equivalent to predicate devices JWX-1 PLUS and e-fix E35/E36 because it shares the same indications for use, similar technological characteristics as powered wheelchair conversion systems, and does not raise new safety or effectiveness questions based on comprehensive non-clinical testing against applicable wheelchair standards.
View the full FDA submission: accessdata.fda.gov