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510(k) Data Aggregation
K Number
K203806Device Name
JWX-1 Plus (Navigo 16/Navigo 24)
Manufacturer
Yamaha Motor CO., LTD.
Date Cleared
2021-05-21
(144 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Yamaha Motor CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device JWX-1 PLUS( NAVIGO 24" ) is a Powered Wheelchair Conversion Kit and suitable for a disabled person who can not walk or have restrictions on walking. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.
Device Description
The JWX-1 PLUS( NAVIGO 16"/NAVIGO 24" ) is an add-on drive for wheelchairs. The JWX-1 PLUS turns a manually propelled wheelchair into a powered wheelchair. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility. The device consists of the left/ right drive units, controller, battery and the battery charger. The drive units replace the original wheels of the manual wheelchair.
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K Number
K140204Device Name
JWX-2
Manufacturer
YAMAHA MOTOR CO., LTD.
Date Cleared
2014-08-28
(213 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
YAMAHA MOTOR CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device JWX-2 is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.
Device Description
The device JWX-2 is an electric power assist unit for wheelchairs that turns a manual wheelchair into a power assisted wheelchair. The device supplies the assist power in response to the wheelchair handrim operating both push-and-brake forces in both directions. The user can operate the wheelchair just like a manual wheelchair with lighter hand force. The device consists of the left/ right power wheel units, battery charger. The power wheel units replace the original wheels of the manual wheelchair. Each power wheel unit has its own hand rim that incorporates the torque sensor which detects the user's operation force. Yamaha Ni-MH battery JWB2 and Yamaha Li-ion battery ESB1 can be used for the device. JWB2 is recharged with the charger JWC-2 and ESB1 is recharged with the charger ESC1. Both batteries can be charged in detached 'desktop' condition and the ESB1 can be charged also on the wheelchair condition. ESB1 does not supply the driving current during the charging to prevent the wheelchair to move. The assist power of the device is adjustable. The wheel locks of the manual wheelchair can be used to prevent the wheelchair from rolling and to keep the wheelchair complete stop like manual wheelchairs with the initial installation adjustment.
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