Mobility Scooter (CL-Q3, CL-Q4)

The Mobility Scooter (CL-Q3, CL-Q4) is a motor-driven indoor and outdoor transportation vehicle designed to provide mobility to disabled or elderly persons limited to a seated position. It features two front wheels, two rear wheels, two support wheels, a seat, tiller console, electric motor, electromagnetic brake, rechargeable battery with off-board charger, and key switch, with movement controlled by throttle lever and speed dial.

The subject device differs from the predicate in several specifications: battery type (Sealed Lead Acid 12V/20Ah×3 or Li-ion 36V/15Ah versus Lithium 25.6Vdc 15Ah), ground clearance (65mm or 60mm versus 20mm), max speed (6 km/h versus 7.92 km/h), max slope (10° or 6° versus 6°), and charger output (DC44.25V/3.0A or DC42V/3.0A versus 29.4V/2A). The submitter asserts these differences do not impact safety or effectiveness when evaluated under applicable ISO 7176 standards.

ISO 7176 series (Parts 1-15, 21-22, 25), ISO 16840-10 (resistance to ignition), IEC 60601-1-2 (electromagnetic compatibility), and ISO 10993 (biocompatibility). The device also received Enhanced-level software documentation in accordance with FDA's 2023 Guidance on device software functions.

Both the subject and predicate devices comply with the same comprehensive ISO 7176 standards and demonstrate equivalent performance across static stability, dynamic stability, braking, distance range, dimensions, mass, seating, durability, obstacle climbing, and EMC testing. The minor parametric differences (battery chemistry, speed, slope rating) do not introduce new safety or effectiveness concerns when evaluated under the same standardized testing framework. No clinical testing was required given the demonstrated substantial equivalence in non-clinical performance data.