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510(k) Data Aggregation

    K Number
    K102355
    Device Name
    ZIP'R MANTIS POWERED WHEELCHAIR
    Date Cleared
    2010-10-04

    (46 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBAL FABTECH WHEELCHAIR (SHANGHAI) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The Zip'r Mantis powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. By providing a powered wheelchair that breaks down into three manageable components (seat set, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
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    K Number
    K102358
    Device Name
    ZIP'R3/ ZIP'R3 XTRA SCOOTER
    Date Cleared
    2010-10-04

    (46 days)

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

    GLOBAL FABTECH WHEELCHAIR (SHANGHAI) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The Zip'r3 and Zip'r3 Xtra scooter are the indoor/outdoor electrical scooter. The design of the scooters is basically similar to other electrical scooters that are already on the market. By providing the electrical scooter that breaks down into three manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc. The Zip'r3 and Zip'r3 Xtra scooters are with a 113 kg (250 lbs) weight capacity. They are basic conventional rear wheel drive, rigid frame vehicle that are battery powered. They consist primarily of a welded steel frame, lighting system, a sealed transaxle motor (155W, DC24V) drive system, electromagnetic braking system, electric motor controller (PG S-Drive 45A) and two batteries with an off-board battery charger (2A). They are powered by two 12 volt lead-acid DC batteries with 16 km (10 miles) with 12 AH which maximum speed upto 6.8 km/hr (4.25 mph).
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    K Number
    K102361
    Device Name
    ZIP'R4/ ZIP'R4 XTRA SCOOTER
    Date Cleared
    2010-10-04

    (46 days)

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

    GLOBAL FABTECH WHEELCHAIR (SHANGHAI) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Zip'r4 and Zip'r4 Xtra scooter are intended for the indoor/outdoor electrical scooter that provide transportation for disabled or elderly persons limited to a seated position. To provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The Zip'r4 and Zip'r4 Xtra scooter are the indoor/outdoor electrical scooter. The design of the scooters is basically similar to other electrical scooters that are already on the market. By providing the electrical scooter that breaks down into three manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc. The Zip'r4 and Zip'r4 Xtra scooters are with a 113 kg (250 Ibs) weight capacity. They are basic conventional rear wheel drive, rigid frame vehicle that are battery powered. They consist primarily of a welded steel frame, lighting system, a sealed powered. Incor (155W, DC24V) drive system, electromagnetic braking system, electric motor controller (PG S-Drive 45A) and two batteries with an off-board battery charger (2A). They are powered by two 12 volt lead-acid DC batteries with 16 km (10 miles) with 12 AH which maximum speed upto 6.8 km/hr (4.25 mph).
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