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510(k) Data Aggregation
K Number
K172409Device Name
Lite
Manufacturer
Tzora Active Systems Ltd.
Date Cleared
2018-05-02
(266 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
Tzora Active Systems Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lite is a mobility assistive device for indoor use and outdoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.
Device Description
The Lite scooter is an electrically powered scooter. It is intended to be used by individuals that are able to walk, but suffer from mobility limitations. The user must have sufficient arm and leg strength to get on and off the Lite alone and to safely steer under all driving conditions. The Lite is intended for indoor use and restricted outdoor use on pavements or paved footpaths only. The Lite can be folded. This allows for easy storage and enables portability of the Lite. The control panel houses all the controls for operating the device. The control panel has a key switch for turning the device on and off, a lever for forward/reverse driving and a knob for speed adjustment. The control panel also contains the control indicator for the status of the device and a battery gauge. The LED control indicator shows the status of the scooter: steady light mean that all is well, blinking indicates an issue. The number of flashes indicate the type of issue. The User Manual contains a troubleshooting section where each type of error and its solution is specified. The steering column can be adjusted and put it in the position which is most comfortable for the operator. The armrests can be lifted to enable easy entry and exit from the scooter.
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K Number
K160835Device Name
Titan 3W
Manufacturer
TZORA ACTIVE SYSTEMS LTD.
Date Cleared
2017-02-02
(314 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
TZORA ACTIVE SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Titan 3W is a mobility assistive device for indoor and outdoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.
Device Description
The Titan 3W scooter is an electrically powered scooter. It is intended to be used by individuals that are able to walk, but suffer from mobility limitations. The user must have sufficient arm and leg strength to get on and off the Titan 3W alone and to safely steer under all driving conditions. The Titan 3W is intended for indoor use and outdoor use. The Titan 3W has reflectors and lights, which should be used in the dark or in limited visibility conditions. The Titan 3W can be folded and disassembled into two parts, the Front Frame and the Rear Frame. Separating both frame parts allows for easy storage and enables portability of the Titan 3W. The Front Frame consists of the steering column, control panel, front wheels, footrest plate and seat. The Rear Frame consists of the motor, controller and battery holders. The control panel houses all the controls for operating the device. The control panel has a key switch for turning the device on and off. a lever for forward/reverse driving, knobs and switches for speed adjustment and lights (front and rear lights, indicators and hazard lights). The control panel also contains the control indicator for the status of the device and a battery gauge. The LED control indicator shows the status of the scooter: steady light mean that all is well, blinking indicates an issue. The number of flashes indicate the type of issue. The User Manual contains a troubleshooting section where each type of error and its solution is specified. The steering column can be adjusted and put it in the position which is most comfortable for the operator.
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K Number
K150086Device Name
Titan
Manufacturer
TZORA ACTIVE SYSTEMS LTD.
Date Cleared
2015-08-05
(202 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
TZORA ACTIVE SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Titan 4W is a mobility assistive device for indoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.
Device Description
The Titan 4W scooter is an electrically powered scooter. It is intended to be used by individuals that are able to walk, but suffer from mobility limitations. The user must have sufficient arm and leg strength to get on and off the Titan 4W alone and to safely steer under all driving conditions. The Titan 4W is intended for indoor use and outdoor use. The Titan 4W has reflectors and lights, which should be used in the dark or in limited visibility conditions. The Titan 4W can be folded and disassembled into two parts. This allows for easy storage and enables portability of the Titan 4W.
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K Number
K052204Device Name
THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER
Manufacturer
TZORA ACTIVE SYSTEMS LTD.
Date Cleared
2006-02-15
(187 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
TZORA ACTIVE SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mobility assistive device for indoor use and outdoor usc on mild terrain. Not used as a transportation vehicle on roads and freeways used by cars.
Device Description
The Elite Scooter is a mobility assistive device for indoor use and outdoor use on mild terrain. The Elite Scooter is an ultra-light, compact, portable vehicle. It is designed for the use of active individuals that are able to walk short distances, but need assistance. The user must have sufficient arms and legs strength to get on and off the Elite on his/her own and to steer without effort under all driving conditions. The maximum allowed weight of the user is 250 lbs. The Elite features the patented Wheel Drive system that incorporates the motor in the front wheel for additional ease of steering. The innovation is restricted to the modification of the design and construction of the hub type magnet brush pancake motor and drive unit. The Elite has the following main components: The Foldable rear frame and the Steering column made from steel tubular welded parts with an oven baked powder coated paint finish. A single drive wheel and two free turning rear wheels. All three wheels are solid. The front wheel size is 10"x2", the rear wheel size is 8"x2". The seat is made from two Polypropylene injected molded vinyl covered foam. The backrest folds down and latches for transportation. The seat is adapted and fitted to the foldable rear-frame. The front wheel drive with a DC permanent magnet brush pancake motor. Because the reduction gear is a spur gear and not worm gear it is a very efficient system. The hub assembly, comprises the drive wheel, pancake shaped PM dc motor, reduction gearbox and an electro-magnetic brake. It has a slick structure, compact dimensions, high efficiency and low noise. It has no moving parts; is fixed to the front fork of the Elite. An electro-magnetic brake connected to its rear shaft. The brake is released electrically by the controller during motor operation, and applied after the motor decelerates and comes to a stop. A mechanical spring automatically applies the brake in case of an electrical failure. The control is a forward/reverse wigwag type that can be operated by both left and right hand. A speed adjustment knob limits the maximum speed. There is a Power On/Off key switch on the control panel, a battery gauge and a LED for low battery and fault condition indication. The brake release toggle is on the control cover. The Controller from Penny and Giles Drives Technologies Ltd. (UK), conforms to all applicable international standards. The 12V battery packs are available in two sizes: the Mini-size pack contains 7.2Ah capacity batteries and the Jumbo size pack -- 12Ah capacity. There is a short-circuit protection fuse in the Battery Pack. The 100-240 VAC charger charges the batteries either directly (off board) or via a socket on the front column with an inhibit feature that does not allow the scooter to be driven when the batteries are being charged. Carrying Basket placed below the seat.
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K Number
K012592Device Name
EASYTRAVEL
Manufacturer
TZORA ACTIVE SYSTEMS LTD.
Date Cleared
2001-10-03
(54 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
TZORA ACTIVE SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mobility assistive device for indoor use and outdoor use on mild terrain. Not used as a transportation vehicle on roads and freeways used by cars.
Device Description
Motorized three wheeled vehicle
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