Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. · Class II · Cleared Mar 17, 2026
| K-number | K252813 |
| Device name | Electrical Scooter (SM4226) |
| Applicant | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. |
| Product code | INI |
| Device class | Class II |
| Decision date | Mar 17, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 890.3800 |
The Electrical Scooter SM4226 is a motor-driven, three-wheeled mobility device for indoor and outdoor use. It provides seated transportation to disabled or elderly persons with a maximum weight capacity of 297 lbs, maximum speed of 4 mph, and cruising range of 6.8 miles per charge.
The SM4226 uses a 270 W brush motor (versus 180 W in the predicate), aluminum alloy frame (versus steel), two 12 Ah lead-acid batteries, PU solid wheels, electromagnetic brake, and includes anti-tip wheels and a tiller-based steering system. Key performance differences include a lower safe climbing angle (6° vs. 9°), lighter weight (73.7 lbs vs. 92.4 lbs), higher maximum load capacity (297 lbs vs. 264 lbs), tighter turning radius, and improved obstacle-climbing ability.
ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation), IEC 60601-1 and IEC 60601-1-2 (medical electrical safety and EMC), and ISO 7176 series standards (wheelchairs) covering static/dynamic stability, brakes, energy consumption, dimensions, strength, climatic testing, obstacle climbing, and battery/charger requirements.
View the full FDA submission: accessdata.fda.gov