(261 days)
The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
The TUNG KENG Electrically Powered Wheelchair, Joy Rider, is suitable for indoor uses. It is characterized by high portability in comfortable travel, small storage and convenient delivery in daily life. As folding of Joy Rider only takes just a few seconds, so this model increases opportunities for travel and provides small storage. To use Joy Rider makes your travel in any place and at any moment! It is an individual transportation vehicle for disabled and elderly people that experience difficulties in walking. The Joy Rider comes as preassembled, designed to be lightweight, easily maneuvered, highly portable, and most importantly, safe and comfortable.
It is driven by two brushless DC motors, and contains two foldable armrests, a seat belt, a backrest, a seat cushion and small with light texture, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, one Lithium-ion battery, an off-board battery charger, a control panel, and an electrical controller.
The device is powered by one 24 VDC/ 10.5 Ah Lithium-ion battery with 9.3 miles cruising range that can be recharged by an off-board battery charger, rated at input: 100-240 VAC / 50-60 Hz, and output: 24 VDC/ 2 A, that can be plugged into an AC outlet, when the device is not in use. Its overall dimensions are 33.6' x 22.6' x 35.8" (855 x 580 x 910 mm). The user can activate the joystick to move in the direction of the joystick is actuated. When the user releases the joystick, the device slows to stop and the brakes are automatically re-engaged. The maximum weight capacity of Joy Rider is 264 lbs. (120 kg) and its maximum speed is 3.75 mph (6 km/h).
I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a medical AI device meets those criteria. The document is a 510(k) submission for an Electrically Powered Wheelchair, named Joy Rider, which is a physical medical device, not an AI-powered diagnostic or therapeutic tool.
The document discusses:
- A 510(k) premarket notification for a powered wheelchair.
- Indications for use, intended user population, and device description.
- Non-clinical performance tests conducted to comply with various ISO and ANSI/RESNA standards relevant to wheelchairs (e.g., static stability, dynamic stability, effectiveness of brakes, speed, obstacle climbing, electromagnetic compatibility).
- Biocompatibility tests for patient-contacting parts.
- A comparison of the subject device (Joy Rider) with a predicate device (Powered Wheelchair, DYW30A(D09)) to demonstrate substantial equivalence, discussing differences in components like motors, wheel sizes, maximum safe operational incline, dimensions, cruising range, and controllers, and asserting that these differences do not raise new safety or effectiveness concerns.
Therefore, I cannot provide the requested information about acceptance criteria and a study for an AI device.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).