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510(k) Data Aggregation

    K Number
    K052558
    Device Name
    VCS, MODEL S4T
    Manufacturer
    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC
    Date Cleared
    2005-10-27

    (41 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VCS S4T scooter is motor driven, indoor and outdoor transportation, vchicles with the intended use to provide mobility to disabled or civerly persons limited to a seated position.
    Device Description
    The VCS S4T scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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    K Number
    K051130
    Device Name
    VCS S3Y
    Manufacturer
    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC
    Date Cleared
    2005-09-09

    (129 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VCS S3Y scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The VCS S3Y scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. The VCS S3Y scooter is with a 136 kg (300 lbs) weight capacity. The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steef frame, rear signal lights, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an on-board charger and an adjustable seat. It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt lead-acid DC batteries with 25 km (15 miles) with 21 AH which maximum speed upto 8.6 km/hr (5.4 mph).
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    K Number
    K051131
    Device Name
    VCS S3T
    Manufacturer
    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC
    Date Cleared
    2005-08-15

    (104 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VCS S3T scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The VCS S3T scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. The VCS S3T scooter is with a 136 kg (300 lbs) weight capacity. The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, rear signal lights, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an on-board charger and an adjustable seat. It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt lead-acid DC batteries with 25 km (15 miles) with 21AH which maximum speed upto 6.6 km/hr (4.1 mph).
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    K Number
    K050507
    Device Name
    SMARTECH, MODEL HOLI I
    Manufacturer
    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
    Date Cleared
    2005-07-07

    (129 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HOLI I scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The HOLI I scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. The HOLI I scooter is with a 130 kg (286 lbs) weight capacity. The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat. It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt lead-acid DC batteries with 27 km (16.9 miles) with 32/36AH which maximum speed upto 9.5 km/hr (5.6 mph).
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    K Number
    K050793
    Device Name
    LANDLEX MODEL S400X
    Manufacturer
    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
    Date Cleared
    2005-07-07

    (101 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LANDLEX S400X scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The LANDLEX S400X scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. The LANDLEX S400X scooter is with a 135 kg (300 lbs) weight capacity. The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, automatic headlight sensor, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat. It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt lead-acid DC batteries with 35 km (22 miles) with 34AH which maximum speed upto 9 km/hr (5.6 mph).
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    K Number
    K050792
    Device Name
    LANDLEX, MODEL S300X
    Manufacturer
    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
    Date Cleared
    2005-04-21

    (24 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LANDLEX S300X scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The LANDLEX S300X scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. The LANDLEX S300X scooter is with a 135 kg (300 lbs) weight capacity. The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, a auto light sensor, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat. It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt lead-acid DC batteries with 35 km (22 miles) with 34AH which maximum speed upto 8 km/hr (5 mph).
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    K Number
    K043326
    Device Name
    BEWELL, MODEL SC 20
    Manufacturer
    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
    Date Cleared
    2005-01-26

    (55 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bewell SC 20 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The Bewell SC 20 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. The Bewell SC 20 scooter is with a 130 kg (286 lbs) weight capacity. The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat. It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt lead-acid DC batteries with 35.2 km (22 miles) with 36AH which maximum speed upto 9 km/hr (5.6 mph).
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    K Number
    K043332
    Device Name
    WHEELCHAIR, MODEL 8500-II
    Manufacturer
    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
    Date Cleared
    2004-12-13

    (11 days)

    Product Code
    IOR, 89I
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AIDC 8500-II Wheelchair is a tilt-in-space mobile positioning system for everyday indoor and outdoor use on flat terrain. They are available in a range of sizes to accommodate a particular fit to the user. AIDC 8500-II Wheelchair can be an attendant propelled or self propelled device, its intended use is to enhance mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor. It has various options to control and/or support the user's specific needs. AIDC 8500-II Wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.
    Device Description
    The AIDC 8500-II Wheelchair is manually operated mechanical wheelchair. It is designed to be light in weight with folding frame. The range of sizes and configurations are available to accommodate the needs of each user. The wheelchair is suitable to provide mobility to user for both indoors and outdoors with firm surface that is free of climbing obstacles. The AIDC 8500-II Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of aluminum alloy frame constructed of AA6061-T6 aluminum alloy tubing that is TIG-welded, removable seat and back upholsteries, flip-up available footrest and legrest, front castors and rear wheels. The owner's manual of AIDC 8500-II Wheelchair provides information on warnings, cautions and operation instruction of the wheelchair.
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