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510(k) Data Aggregation

    K Number
    K220227
    Device Name
    Auto Folding Scooter, S21F
    Manufacturer
    Heartway Medical Products Co., Ltd.
    Date Cleared
    2022-10-12

    (258 days)

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

    Heartway Medical Products 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 Auto Folding Scooter S21F is designed for indoor use for adults with mobility restrictions. It is classified as Class II medical device per US FDA 21 CFR 890.3800. It is compact, maneuverable and not necessarily able to overcome obstacles. The maximum load is 115 kg. The product is not intended for visually impaired people. The drivers need to be mentally and physically suitable to drive the scooters. The fingers need to work functionally. The driving distance will be reduced if the scooter is used frequently on slopes, rough ground or climbing curb. The scooter is not for use as a seat in motor vehicle. Auto Folding Scooter S21F is battery powered and configured with four solid wheels (03) (08), a seat (04), a handle bar to control the driving function (01), a cross bar (05), a main frame (06), a foot-rest (02), a back-rest (04), a set of 2 anti-tippers (09), referred to the components and parts diagrams of S21F below. S21F is driven by two solid rear wheels (08) as the drive wheel, two solid front castors (03) as the steering wheel, using the steering handles (01) to control the front frame assembly (02) to control the front wheels (03) as the power scooter steering direction mechanism. Steering handles (01) is able to control driving forward, driving backward, speed control. The main frame (06) is equipped with a rear bumper to allow the scooter to sustain an impact without damage to the power scooter safety system. The maximum loading weight of S21F is 253 lbs. (115 kg), and its maximum speed is 3.75 mph (6 km/h). The dimensions of (Length * Width *Height) of the unfolded device are 33.0" x 18.1" x 30.3" (840 mm x 460 mm x 770 mm) and 28.7" x 17.3" x 16.5" (730 mm * 420 mm * 420 mm) for the folded device. The weight of the device is 51.8 lbs. (23.5 kg) with battery and 46.9 lbs. (21.3 kg) without battery. Seat belt is a standard accessory to S21F power scooter, and is not a 510(k)-clearance accessory. It can be installed onto the seat (as seen in the diagram below) by consulting with the local authorized dealer for seat belt installation.
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    K Number
    K151656
    Device Name
    HEARTWAY Power Mobility Scooter
    Manufacturer
    HEARTWAY MEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2015-11-25

    (159 days)

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

    HEARTWAY MEDICAL PRODUCTS 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
    Cutie S17 power scooter is battery powered and configured with four pneumatic wheels, a swivel seat, a turning tiller column, an upper panel control, a main frame, a rear bumper, a front bumper, and an anti-tipper. S17 power scooter is operated by two pneumatic rear wheels as the drive wheels and two pneumatic front wheels as the steering wheels, using the upper panel control to control the turning tiller column mechanism to control the front wheel as the power scooter steering direction mechanism. Upper panel control is able to control driving forward, driving backward, speed control and lighting function. The main frame is equipped with a rear bumper and a front bumper to allow the scooter to sustain an impact without damage to the power scooter safety system. Turning tiller column is equipped with the head light, back mirrors, a swivel seat with the flipping arm-rests, and a lever to move the seat backward and forward.
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    K Number
    K150998
    Device Name
    HEARTWAY Power Mobility Scooter
    Manufacturer
    HEARTWAY Medical Products Co., Ltd.
    Date Cleared
    2015-09-29

    (167 days)

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

    HEARTWAY Medical Products 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
    Cutie Mini S16 is battery operated and configured with two rear pneumatic wheels as the drive wheels and two front pneumatic wheels as the steering wheels. The device uses the upper panel control to control the turning tiller column mechanism to control the front wheel as the steering directions. Upper panel control is able to control driving forward, driving backward, speed control and lighting function. The main frame is equipped with a rear bumper to allow the device to sustain an impact without damage to the power scooter safety system and with an independent suspension. Tuning tiller column is equipped with the head light, back mirrors, and a swivel seat with the flipping arm-rests, and a lever to move the seat backward and forward. Cutie Mini S16 maximum weight capacity is 300 lbs (135 kg), and the maximum speed is 3.6 mile/hr ( 6 km/hr). Owing to the feature of the body structure, the two rear wheels can always contact the surface, and the device can drive on the rough surface.
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    K Number
    K150987
    Device Name
    HEARTWAY Power Mobility Scooter, BRIO S19
    Manufacturer
    HEARTWAY Medical Products Co., Ltd.
    Date Cleared
    2015-09-22

    (161 days)

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

    HEARTWAY Medical Products 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
    BRIO S19 power scooter is battery powered and configured with four solid wheels, a seat, a turning tiller column, a upper panel control, a main frame, a cross bar and an anti-tipper. BRIO S19 power scooter is operated by two rear wheels as the drive wheels and two front wheel as the steering wheel, using the upper panel control to control the turning tiller column mechanism to control the front wheel as the power scooter steering direction mechanism. Upper panel control is able to control driving forward, driving backward, speed control. The main frame is equipped with a rear bumper to allow the scooter to sustain an impact without damage to the power scooter safety system. BRIO S19 power scooter maximum weight capacity is 220 lbs (100 kg), and BRIO S19 power scooter maximum speed is 5 mile/hr (8 km/hr).
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    K Number
    K142783
    Device Name
    HEARTWAY Electrically Powered Wheelchair P27
    Manufacturer
    HEARTWAY Medical Products Co., Ltd.
    Date Cleared
    2015-06-12

    (259 days)

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

    HEARTWAY Medical Products 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 HEARTWAY Electrically Powered Wheelchair, Model P27 is battery powered and configured with 2 PU solid front castors and 2 pneumatic rear drive wheels, a width adjustable seat, a controller to control the lighting function and driving function, a main frame, a foot-rest, a pair of arm-rest, a back-rest, a seat cushion, a pair of skirts, a set of anti-tippers. P27 powered wheelchair is rear-wheel driven and operated by two pneumatic rear wheels as the drive wheels, two solid front wheels as the front casters and uses upper joystick to control the driving direction, driving speed, and lighting function. Main frame carries a width adjustable seat system and a set of anti-tipper to prevent a patient from tipping their wheelchairs backward. Main frame is equipped with the front & rear independent suspensions to enhance the stability. A width-adjustable seat system carries a set of back rest system, a seat cushion, a pair of arm-rest, a pair of foot-rest, and a pair of skirts to provide seat posture positioning functions. P27 power wheelchair maximum weight capacity is 265 lbs (120kg). Maximum speed is 3.75 mph (6 kph). The device can be disassembled for transport and is provided with an external battery charger.
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    K Number
    K142731
    Device Name
    HEARTWAY Electrically Powered Wheelchairs
    Manufacturer
    HEARTWAY Medical Products Co., Ltd.
    Date Cleared
    2015-02-27

    (157 days)

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

    HEARTWAY Medical Products 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 HEARTWAY Electrically Powered Wheelchair, Model P19 is battery powered and configured with four solid wheels, a seat, a controller to control the driving function, a main frame, a foot-rest, a pair of arm-rest, a back-rest, and a set of anti-tippers. Main frame carries a width foldable seat system and a set of rear anti-tipper to prevent a patient from tipping their wheelchairs backward. P19 maximum weight capacity is 250 lbs (113kg). Maximum speed is 3.75 mph (6 km per hour). The device can be folded for transport and is provided with an external battery charger.
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    K Number
    K132855
    Device Name
    HEARTWAY POWER MOBILITY SCOOTER
    Manufacturer
    HEARTWAY MEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2014-08-29

    (351 days)

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

    HEARTWAY MEDICAL PRODUCTS 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 HEARTWAY Power Mobility Scooter. S15 is an indoor / outdoor powered scooter that is battery operated. It has a base with four-wheeled with a seat, and armrests. The movement of the powered 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 external battery recharger.
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    K Number
    K132856
    Device Name
    HEARTWAY POWER WHEELCHAIR
    Manufacturer
    HEARTWAY MEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2014-07-15

    (306 days)

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

    HEARTWAY MEDICAL PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The HEARTWAY Power Wheelchair, P25 is an indoor / outdoor power chair that is battery operated. It has a base with four-wheeled with a seat, and armrests. The movement of the power chair 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 external battery charger.
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    K Number
    K101142
    Device Name
    HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34
    Manufacturer
    HEARTWAY MEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2010-05-26

    (34 days)

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

    HEARTWAY MEDICAL PRODUCTS 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 HEARTWAY Lightweight Power Mobility Scooter, S34 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.
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    K Number
    K101143
    Device Name
    HEARTWAY POWER MOBILITY SCOOTER, S11
    Manufacturer
    HEARTWAY MEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2010-05-26

    (34 days)

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

    HEARTWAY MEDICAL PRODUCTS 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 HEARTWAY Power Mobility Scooter. S11 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.
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