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510(k) Data Aggregation
(184 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The Electric Scooter, has a base with metal frame, two front wheels, two rear wheels, a seat, a LCD Display, electric motor, electromagnetic brake, 1 rechargeable Lithium Battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the control lever, speed control turn "speed" Knob. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat surface. The device can be folded from front to back. Till height and armrest width is adjustable.
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(184 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The Electric Scooter, has a base with metal frame, two front wheels, two rear wheels, a seat, a LCD Display, electric motor, electromagnetic brake, 1 rechargeable Lithium Battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the control lever, speed control turn "speed" Knob. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat surface. The device can be folded from up to down by manual.
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(191 days)
The electric scooter is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The electric scooter is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The Mobility Scooter, Model DDF100, consists with two front wheels, two rear wheels, two rear anti-tip wheels, one seat system with one back support and two arm supports, an adjustable steering column, a tiller console, an electric motor, an electromagnetic brake, one rechargeable Lithium-Ion battery and one off-board charger.
The movement of the wheelchair is controlled by the speed lever and steering column. The device is installed with an electromagnetic brake that will engage automatically when the wheelchair is not in use and the brake can be manually adjusted to free wheel mode. The scooter only can be operated on the flat road.
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(71 days)
The manual wheelchair is to provide mobility to persons limited to a sitting position.
A wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. The device is intended for adults only.
W50 is a mechanical wheelchair including four wheels, a steel frame cover black paint and a textilene upholstery that is flame resistant. W50 has a physical dimension of 1130mm x 840mm x 950mm (depth x width x height) with the seat itself has a dimension of 525mm x590mm x 470mm (depth x width x height). The device has a weight capacity of 227 kilograms, and weighs about 24 kilograms. The color is dark black.
Occupant mass group of the manual wheelchair belongs to III. Armrest is non flip back/non height adjustable. Rear axle is offset axle, quick release axle.
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(245 days)
The Hand Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health.
The Hand Massager is indicated for temporary relief of minor muscle aches and pains and for a temporary increase in circulation to the treated areas in generally healthy adults.
This hand massager is intended for use by healthy adults to temporarily relieve minor muscle aches and pains in the hand and wrist and to temporarily increase local circulation. It is particularly suitable for relaxing hand muscles after repetitive activities.
Charge this product using the supplied USB cable and a 5 V USB power adapter (1 A or 2 A). Do not use rapid/fast charging or a power adapter that outputs more than 6 V. The power indicator flashes during charging and turns off when fully charged. This product cannot be turned on or operated while it is being charged.
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(108 days)
CoolTone device is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen
- Strengthening, toning and firming of buttocks and thighs
When intended to stimulate healthy muscles to improve or facilitate muscle performance, CoolTone induces muscle contractions to enhance muscle function and may therefore be considered a technique of muscle training.
In addition, the CoolTone is indicated to be used for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle reeducation
- Maintaining or increasing the range of motion
CoolTone may also be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. Furthermore, CoolTone device may be used to stimulate neuromuscular tissue for bulk muscle excitation in the legs for rehabilitative purposes.
The CoolTone system is a non-invasive, therapeutic device. The device produces an electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, CoolTone helps to strengthen, tone and firm the abdomen, buttocks and thighs.
The device is a mobile standalone unit with four wheels, and the device housing protects the patient from electrical shock and mechanical injury.
Two large applicators are connected to the control unit and can be used simultaneously depending on the treatment. The device is a medical equipment that generates a magnetic field by applying a strong current to an applicator. CoolTone is equipped with a securement system, designed to maintain the position of the applicator throughout treatment.
A large color touch screen facilitates the use of the device. The on-screen information guides the user, step-by-step, through the entire treatment process. The treatment is operated through variable parameters such as frequency, time and intensity. Three pre-set treatment options are available for users to choose from: Abdomen, buttocks and thighs.
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(248 days)
This Electric Wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The product is intended only carry one person and used as a means of transportation for people with disabilities or incomplete walking ability (excluding obesity).
The electric wheelchair is classified as class A, which is suitable for use on flat walking paths indoors and near buildings.
The maximum occupant mass is 100kg.
The Electric Wheelchair is a battery powered four wheeled vehicle.
It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery power indicator, ON/OFF button, horn button, speed indicator, speed control button, joystick, lighting switch, USB interface), arm supports, two rear wheels, two casters(front wheels), Foot support, anti-tip devices.
The wheelchair can easily fold and unfold for transportation or storage.
The controller handle (joystick) is equipped on the control pad that attaches to the right arm rest. While there is a bluetooth music play function equipped on the left arm rest. The bluetooth function does not connect to the controller, so it will not affect the normal operation of the wheelchair at all.
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(108 days)
The intended use of the Electric Wheelchair (Robooter E80), Model name: BBR-E80-01 and BBR-E80-02 is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
The Electric Wheelchair (Robooter E80), Models name: BBR-E80-01,BBR-E80-02, is an indoor/outdoor, battery- operated, 2-wheel drive (rear-wheel drive) powered wheelchair.
It consists of four modules: seat system, control system, braking system, and drive system. The user sits in the wheelchair seat and uses the control system.
The control pad positioned on the right armrest, user can turn the wheelchair on, control the speed, and direct the movement.
The braking system employs an electromagnetic brake, when release the controller rocker, the electromagnetic brakes will be actuated, and the electric wheelchair will stop in several seconds. Electromagnetic brake will not take effect immediately, it will take effect after the wheel rotates for 1/2 cycle.
The wheelchair is powered by a 24V DC,12Ah or 20Ah rechargeable lithium-ion battery charged by an offboard lithium-ion battery charger. The wheelchair is driven by two DC motors.
The Electric Wheelchair (Robooter E80), Models name: BBR-E80-01,BBR-E80-02, contains Bluetooth 4.1 BLE technology. The device can be controlled by the controller rocker or remote control by a smartphone app via Bluetooth 4.1 Low Energy (BLE) wireless communication interface. The smartphone app is used to drive the chair remotely. For safety, controller rocker control is priority over the remote control by design. The smartphone app can also view the battery's status, adjust the speed gear level and lock/unlock the unattended device.
The wheelchair can be folded/expanded manually. The Left and right handrails (joystick) can be interchange.
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(206 days)
The EmpowerRide NAVIGATOR is a manual wheelchair; it is intended to provide mobility to children with disabilities who are partially or permanently non-ambulatory and limited to a sitting position.
The EmpowerRide NAVIGATOR is a manual pediatric wheelchair intended to provide mobility to children with disabilities who are partially or permanently non-ambulatory and limited to a seated position.
It is designed for caregiver propulsion and is suitable for everyday use in indoor and outdoor environments with flat, firm terrain. The device includes modular adaptive seating and postural supports to meet the therapeutic and mobility needs of pediatric users with neuromuscular, developmental, or orthopedic conditions.
The NAVIGATOR may be used under the supervision of a healthcare provider or selected independently by caregivers for non-complex pediatric mobility needs. The device has been tested and meets the applicable performance and safety requirements of RESNA WC-1:2019 and ISO 7176 standards for manual wheelchairs.
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(108 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The Mobility Scooter(Air Classic, Air Traveller, and Air Traveller 2.0) feature a base with an aluminum frame and an ABS body shell. They come equipped with one or two front wheels, two rear wheels, two armrests, a seat, a control panel, direction handles, electrical machinery, an electromagnetic brake, and rechargeable lithium-ion batteries with an off-board charger.The movement of the scooter is controlled by control panel and direction handles.
The device is installed with an electromagnetic brake.Seat and handlebar can be folded.The maximum load capacity is 120KG.
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