Search Filters

Search Results

Found 23 results

510(k) Data Aggregation

    K Number
    K192308
    Device Name
    Wu's Electrical Scooter
    Manufacturer
    Wu's Tech Co., Ltd.
    Date Cleared
    2020-12-21

    (483 days)

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

    Wu's Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    The Wu's Electrical Scooter, WT-M4JKx, is an indoor-use electrical scooter that is battery operated. It has a base with 4 wheels, a seat and 2 armrests. The movement of the electrical scooter is controlled by the rider who uses speed control lever to control the direction and speed of an electrical scooter. The motor power is 470W. The device uses a PG S-Drive 70A electronic controller. The device is provided with an off-board battery charger (Input: AC100-240V, Output: DC 24V, 5 Amp). The maximum weight capacity of WT-M4JKx is 400 lbs (182 kg), and its maximum forward speed is 5.9 mph (9.5 km/h).
    Ask a Question
    K Number
    K181163
    Device Name
    Wu's Powered Wheelchair
    Manufacturer
    Wu's Tech Co., Ltd.
    Date Cleared
    2019-02-16

    (291 days)

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

    Wu's Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    The Wu's Powered Wheelchair, Mambo 30, is an indoor-use electric wheelchair that is battery operated. It has a base with six-wheeled with a seat and armrest. The movement of the wheelchair is controlled by the rider who uses joystick, located at the right-side armrest, to control the direction and speed of the wheelchair. The device is provided with an off-board battery charger. The maximum weight capacity of Mambo 30 is 300 lbs. (136 kg), and its maximum speed is 4 mph (6.4 km/h).
    Ask a Question
    K Number
    K091212
    Device Name
    WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H
    Manufacturer
    WU'S TECH CO., LTD.
    Date Cleared
    2009-05-27

    (30 days)

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

    WU'S TECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The WU'S SCOOTER WT-T3H is an indoor / outdoor electric scooter that is battery operated. It has a base with three-wheeled, a seat, two armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
    Ask a Question
    K Number
    K082963
    Device Name
    WU'S 4-WHEELED NEO SCOOTER, WT-M3A
    Manufacturer
    WU'S TECH CO., LTD.
    Date Cleared
    2008-11-24

    (52 days)

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

    WU'S TECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The WU'S SCOOTER WT-M3A is an indoor / outdoor electric scooter that is battery operated. It has a base with three-wheeled, a seat, two armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
    Ask a Question
    K Number
    K072337
    Device Name
    WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A
    Manufacturer
    WU'S TECH CO., LTD.
    Date Cleared
    2007-09-21

    (32 days)

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

    WU'S TECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The WU'S SCOOTER WT-M4A is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
    Ask a Question
    K Number
    K070655
    Device Name
    WU'S POWERED WHEELCHAIR, MAMBO 36
    Manufacturer
    WU'S TECH CO., LTD.
    Date Cleared
    2007-04-02

    (24 days)

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

    WU'S TECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The WU'S Powered Wheelchair MAMBO 36 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
    Ask a Question
    K Number
    K062790
    Device Name
    WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E
    Manufacturer
    WU'S TECH CO., LTD.
    Date Cleared
    2006-10-11

    (23 days)

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

    WU'S TECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The WU'S 3-WHEELED NEO SCOOTER WT-T3E is an indoor / outdoor electric scooter that is battery operated. It has a base with three-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
    Ask a Question
    K Number
    K052559
    Device Name
    WU'S POWERED WHEELCHAIR, MAMBO 2
    Manufacturer
    WU'S TECH CO., LTD.
    Date Cleared
    2005-09-26

    (10 days)

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

    WU'S TECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The WU'S Powered Wheelchair MAMBO 2 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
    Ask a Question
    K Number
    K050042
    Device Name
    WU'S 4-WHEELED NEO SCOOTER, WT-XL4
    Manufacturer
    WU'S TECH CO., LTD.
    Date Cleared
    2005-03-14

    (66 days)

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

    WU'S TECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The WU'S 4-WHEELED SCOOTER WT-XL is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
    Ask a Question
    K Number
    K050010
    Device Name
    WU'S POWERED WHEELCHAIR, MAMBO 36X
    Manufacturer
    WU'S TECH CO., LTD.
    Date Cleared
    2005-02-11

    (39 days)

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

    WU'S TECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The WU'S Powered Wheelchair MAMBO 36X is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
    Ask a Question

    Page 1 of 3