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510(k) Data Aggregation
K Number
K242760Device Name
WHILL Model R
Manufacturer
Whill, Inc.
Date Cleared
2025-01-06
(116 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
Whill, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Model R 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.
Device Description
WHILL Model R is an indoor/outdoor electric scooter that is intended as a mobility aid for elderly persons or persons with reduced mobility. Providing Bluetooth-based radio communications functionalities. Model R is available in two variants, the 3-wheel model and the 4-wheel model. The 3-wheel scooter has a base with metal alloy frame, one front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a tiller console, 2 electric motors, 2 electromagnetic brakes, a rechargeable lithium-ion battery with an off-board charger. The 4-wheel scooter has a base with metal alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a tiller console, 2 electric motors, 2 electromagnetic brakes, a rechargeable lithium-ion battery with an off-board charger. The only difference between 3-wheel model and 4-wheel model is front drive-base component. The 3-wheel model has a single front tire, while the 4-wheel model has two front tires. Besides this difference in mechanical design, other parts of the device are identical across the two models. Customers can choose a model depending on their preferences and use case. Model R has a removable lithium-ion battery, a swivel 17-inch-wide seat with two armrests and front and rear LED lights. The battery may be charged either when installed within the device or when removed. Some components are adjustable to provide user with a comfortable riding position. The inner width and the height of the armrests are adjustable in 3 positions. The seat position from the tiller is adjustable in 4 positions. The seat height is adjustable in 2 positions and the tiller angle is also adjustable. A lap belt is equipped for posture support and for safety. As with all conventional powered scooters, to drive the Model R, the user sits in the seat and grips the tiller handle around the controller unit which is positioned in front of the user. While gripping the tiller handle, the user uses their fingers to pull the right side of the throttle control lever gently to drive the device forward. The degree at which the throttle control lever is pulled is positively proportional to the speed of the device. When the throttle control lever returns to its original position after the user releases it, the device decelerates and comes to a stop. When the user uses their fingers to pull on the left side of the lever, the device drives backwards. To move to the left, the user turns the tiller handle to the left, and, to the right, the user turns the tiller handle to the right. Model R has Bluetooth-based radio communications capabilities. The user can power on Model R with a physical key, a Bluetooth smart key fob or with a dedicated smartphone app. The user can select speed profiles, turn off and on the front LED light and sound the audible warning device by operating the controller unit. User can disassemble Model R into four components, i.e. drive base, main body, seat base assembly and battery, without the use of tools when loading into a car for transportation. The device supports a maximum weight of 147 kg (325 lbs.), including the weight of the occupant and any carried items. The 3-wheel model has a theoretical continuous driving range of 18.7 km (11.6 miles) while the 4-wheel model has a theoretical continuous driving range of 17.2 km (10.7 miles).
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K Number
K221438Device Name
WHILL Model F
Manufacturer
Whill, Inc.
Date Cleared
2022-06-07
(21 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Whill, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the WHILL Model F powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Device Description
The subject device is an update to the existing previously cleared WHILL Model C2 (K213383) (hereafter the "predicate device"). The WHILL Model F is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair. It has two arm rests, a seat belt, a foldable backrest, a seat cushion, a foldable frame, two motors, two electromagnetic brakes, an electric motor controller, and a lithium-ion battery with a dedicated off-board battery charger. The wheelchair is powered by a 25.3 V DC 10.6A rechargeable lithium-ion battery charged by an off-board lithium-ion battery charger. The control system, including the directional controller (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop. As with all conventional powered wheelchairs, the user sits in the wheelchair seat and uses the control system such as the control pad positioned on either of the two arms to turn the chair on, control the speed, and direct the movement. Adjustments can be made to the arm rests to fit the user's body. The space between the two arms and the height of the arm rests can be adjusted based on the user's seating requirements. Model F contains a new folding feature, not available on the predicate device. The foldable technology is like the legally marketed DYW30A(D09) powered wheelchair (K170787) (hereafter the "reference device"). The subject device can be controlled by the directional controller or remote control by a smartphone app via Bluetooth Low Energy (BLE) wireless communication interface. The smartphone app can also display the battery's status, adjust the speed and acceleration setting and lock the unattended device. The user can lock and unlock the device remotely via the BLE interface using the smartphone app or using a smart key. The device supports a maximum weight of 253.5lb (115 kg), including the weight of the occupant and any carried items. It has a maximum driving range of 12.4 miles (20 km) with a maximum speed limit of up to 3.7mph (6 km/h).
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K Number
K213383Device Name
WHILL Model C2
Manufacturer
Whill, Inc.
Date Cleared
2021-11-09
(27 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Whill, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the WHILL Model C2 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Device Description
The subject device is an update to the existing previously cleared WHILL Model M (K153543). The WHILL Model C2 is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair. It consists of four parts: seat system, braking system, and drive system. It consists of two motors drive systems, an electromagnetic braking system, an electric motor controller, and a lithium-ion battery with an off-board battery charger. The wheelchair is powered by a 25.3V DC 10.6A rechargeable lithium-ion battery charged by an offboard lithium-ion battery charger.
The control system, including the directional controller (joystick), is equipped on the control pad that attaches to the armrest. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.
As with all commercially available powered wheelchairs, the user sits in the wheelchair seat and uses the control system such as the control pad positioned on either of the two arms to turn the chair on, control the speed, and direct the movement. Adjustments can be made to the seating to fit the user's body. Like the predicate device WHILL Model M, the two side-arms can be rotated out of the way to make it easier for the user to get into and out of the device.
Model C2 also contains Bluetooth-based RF wireless technology. The wireless technology is identical to the legally marketed reference device 2, e-motion-M25 (K192618). The device can be controlled by the directional controller or remote control by a smartphone app via Bluetooth Low Energy (BLE) wireless communication interface. The smartphone app is used to drive the chair remotely. (Note: For safety, Joystick control is priority over the remote control by design.) The smartphone app can also view the battery's status, adjust the speed and acceleration setting and lock the unattended device. The user can lock and unlock the device remotely via the BLE interface using the smartphone app or using a smart key fob.
The device supports a maximum weight of 136Kg (300lbs.), including the weight of the occupant and any carried items. It has a maximum driving range of 11miles (18km) with a maximum speed limit of up to 5mph (8km/h).
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K Number
K153543Device Name
WHILL Model M
Manufacturer
WHILL, INC.
Date Cleared
2016-02-12
(63 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
WHILL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Model M powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Device Description
The WHILL Model M is an indoor/outdoor battery-operated 4 wheel drive powered wheelchair. It is powered by two 12 VDC 50Ah batteries and controlled by the R-net 120 amp motor controller. As with all commerciallyavailable powered wheelchairs, the user sits in the wheelchair seat and uses controls positioned on the arms to turn the chair on, control the speed, and direct the movement. The directional controller can be mounted on the left or right arm. When the user activates the directional controller the brakes are released and the motors rotate to move the device in the desired direction. When the user releases the directional controller the device is brought to a controlled stop. The chair frame is a welded nut and steel construction and includes two rear wheels with drive units (motor, gear and brake) connected by belts to the front all directional wheels. Adjustments can be made to the two arm supports, foot support, and seat height and depth to position the user correctly in the device. The device supports a maximum weight of 220 lb, and has an approximate driving range of 12 miles. The device can be operated on carpet, tile, wood, vinyl, concrete, blacktop, dirt, gravel, grass, and wet (<1" standing water) surfaces.
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