Search Results
Found 11 results
510(k) Data Aggregation
K Number
K190737Device Name
Solax Electric Scooter (Models: S204311M, S204161, S204143)
Manufacturer
Dongguan Prestige Sporting Goods Co., Ltd.
Date Cleared
2021-05-10
(780 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Prestige Sporting Goods Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The Solax Electric Scooter (Models: S204311M, S204161, S204143) is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk, but suffer from mobility limitations. It has the following main components: two 6 inch solid front tires, two 7 inch solid rear tires, two anti-tip tires, control panel, steering handles, seat folding lever, backrest, arm rest, seat, steering column, seat frame, front/ rear covers, folding release lever, angle adjustment lever, height adjustment lock, carry handle, an off-board charger and aluminum alloy made frame, It is powered by two Li-ion DC rechargeable batteries with 18 km (on level surface) which maximum speed up to 6 km/hr. The movement of the scooter is controlled by the steering handles and control panel. 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.
Ask a Question
K Number
K192190Device Name
Solax Electric Scooter
Manufacturer
Dongguan Prestige Sporting Goods Co., Ltd
Date Cleared
2021-04-23
(619 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Prestige Sporting Goods Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
Not Found
Ask a Question
K Number
K200978Device Name
Electric Wheelchair (Model: S7110)
Manufacturer
Dongguan Prestige Sporting Goods Co., Ltd.
Date Cleared
2021-04-16
(368 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Prestige Sporting Goods Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electric wheelchair (Model: S7110) is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly limited to a seated position.
Device Description
Not Found
Ask a Question
K Number
K202632Device Name
Electric wheelchair (S7204/S7205)
Manufacturer
Dongguan Prestige Sporting Goods Co., Ltd.
Date Cleared
2021-04-08
(209 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Prestige Sporting Goods Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a power wheelchair intended to provide mobility to persons restricted to a sitting position.
Device Description
The Electric wheelchair (Model S7204, S7205) is a power wheelchair intended to provide mobility to persons restricted to a sitting position. The Electric wheelchair (Model S7204, S7205) is about 136 kg weight capacity. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a welded-aluminum frames, sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and Li-ion batteries with an off-board battery charger. It is powered by rechargeable batteries with 45 km which maximum speed up to 7 km/h. The controller with a joystick attaches to either armrest and allows the rider to control the movement and velocity of the powered wheelchair. When the joystick is released. the electromagnetic brake will be actuated and the power wheelchair is slow to stop. It consists of three parts which are chair part, control part and drive part. Overall it mainly has a basic aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a footrest, an controller, an electric motor, an electromagnetic brake and a Lithium battery with an off-board charger. The result of "tiltover" tests performed laterally (12° ), posteriorly (16° ), and anteriorly (12° ) with a user of maximum allowable weight in the least stable configuration: No overturn performed laterally, posteriorly, and anteriorly with 136kg in the least stable configuration.
Ask a Question
K Number
K201508Device Name
Infrared Thermometer
Manufacturer
Dongguan Prestige Sporting Goods Co., Ltd
Date Cleared
2021-03-09
(277 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Prestige Sporting Goods Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Infrared Thermometer (model: STM-20) is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
Device Description
Infrared Thermometer (model: STM-20) is a hand-held, battery powered, non-contact infrared thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead, to an oral equivalent temperature when placed within 1-3 cm from the subject's forehead with no contact. The Infrared Thermometer referenced body site is oral temperature. The laboratory accuracy of rated output temperature range 34°C-42°C (93.2°F to 107.6°F) is ±0.2°C (0.4°F). The rated extended output range is 32°C~33.9°C (89.6°F to 93.0°F), 42.1°C~43°C (107.8°F to 109.4°F) and the laboratory accuracy is ±0.2°C (0.4°F) as well. The device can be used in the hospital or at home.
It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings.
It composed by a measuring sensor, PCB, 3 buttons, a LCD and an enclosure. Press the measurement key to turn on the device. The screen of the device lights up. The LCD screen has the power symbol, measurement mode, temperature unit and measurement temperature. When measuring body temperature, users need to keep the measurement distance 1-3 cm from the subject's center of forehead with no contact. Press the measuring key, after 1 second with the sound of "beep", the measurement is completed and the temperature is displayed on the LCD screen. Without any operation, it will close automatically in 30±5 seconds.
User contacts components are the enclosure and keys. The materials of the components are ABS plastic and it no any color additives.
Ask a Question
K Number
K202549Device Name
Solax Electric Scooter (Model: S202261B)
Manufacturer
Dongguan Prestige Sporting Goods Co., Ltd
Date Cleared
2021-02-26
(176 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Prestige Sporting Goods Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
Solax Electric Scooter (Model: S202261B)
Ask a Question
K Number
K191897Device Name
Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)
Manufacturer
Dongguan Prestige Sporting Goods Co., Ltd.
Date Cleared
2021-02-10
(575 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Prestige Sporting Goods Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
Not Found
Ask a Question
K Number
K200857Device Name
Electric wheelchair (Model: S7012)
Manufacturer
Dongguan Prestige Sporting Goods Co., Ltd.
Date Cleared
2020-12-17
(260 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Prestige Sporting Goods Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electric wheelchair is a motor driven transportation vehicle with the intended use to provide mobility to a disabled or elderly limited to a seated position.
Device Description
The Electric wheelchair (Model S7012) is to provide mobility to adults, limited to a seated position that have capability to operate a few simple controls and the ability to control a powered wheelchair. The device and accessories (remote controller, AC power wire, charger, and battery) are reusable. The Electric wheelchair (Model S7012) is about 125 kg weight capacity and size is about 840mm x 640mm x 930mm if unfold and about 700mm x 640mm x 370mm if fold. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a foldable welded-aluminum frames, sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and Li-ion batteries with an off-board battery charger. It has some components as two front wheels, two rear wheels, two anti-tip wheels, a seat, a footrest, and has a remote for folding/unfolding the device. Its basic function is powered by rechargeable batteries with 15 km which has a maximum speed up to 6 km/h. The controller with a joystick attaches to either armrest and velocity of the powered wheelchair. When the joystick is released, the electromagnetic brake will be actuated and the power wheelchair is slow to stop. The joystick can move up and down, left and right. There is a speed button to adjust the speed, and the speed indicator can display the speed. In addition, there is a remote control to control the folding and unfolding of the device. And no any new features of the device.
Ask a Question
K Number
K182400Device Name
Solax Powered Wheelchair (Models: S7101, S7103)
Manufacturer
Dongguan Prestige Sporting Goods Co., Ltd
Date Cleared
2020-04-14
(588 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Prestige Sporting Goods Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Solax Powered Wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Device Description
Not Found
Ask a Question
K Number
K182576Device Name
Solax Powered Wheelchair
Manufacturer
Dongguan Prestige Sporting Goods Co., Ltd
Date Cleared
2019-05-21
(244 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Prestige Sporting Goods Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Solax Powered Wheelchair is to provide mobility to adults, limited to a seated position that have capability to operate a few simple controls and the ability to control a powered wheelchair.
Device Description
The Solax Powered Wheelchair (Model S7102) is to provide mobility to adults, limited to a seated position that have capability to operate a few simple controls and the ability to control a powered wheelchair. The Solax Powered Wheelchair (Model S7102) is with 100 kg (220 lbs) weight capacity. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a foldable welded-aluminum frames, two sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and two Li-ion batteries with an off-board battery charger. It is powered by rechargable batteries with 27.65 km which maximum speed upto 6.2 km/hr. The controller with a joystick attaches to either armrest and allows the rider to control the movement and velocity of the powered wheelchair. When the joystick is released, the electromagnetic brake will be actuated and the power wheelchair is slow to stop.
lt consists of four parts which are chair part, control part, folding part and drive part. Overall it mainly has a basic aluminum alloy frame, two front wheels, two anti-tip wheels, a seat, a footrest, an controller, an electric motor, an electromagnetic brake, a remote for folding the device and a Lithium battery with an off-board charger.
Ask a Question
Page 1 of 2