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510(k) Data Aggregation
K Number
K240105Device Name
Navigator (FMNVG15); Navigator XL (FMNVX06)
Manufacturer
Date Cleared
2024-08-29
(226 days)
Product Code
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Forcemech International LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Navigator (model: FMNVG15) and Navigator XL (model: FMNVX06) 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 Navigator (model: FMNVG15) and Navigator XL (model: FMNVX06) is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.
The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, safety belt, pedal, battery box and charger. The device is powered by Li-ion Battery pack (24V 6Ah*2) with 16 Km range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.
The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
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