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510(k) Data Aggregation

    K Number
    K250758
    Device Name
    Electric Wheelchair (F309)
    Date Cleared
    2025-05-09

    (57 days)

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

    CHANGSHU PINGFANG **WHEELCHAIR **CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This Electric Wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
    Device Description
    The product is intended only carry one person and used as a means of transportation for the disabled, and sick. The electric wheelchair is classified as class B and the maximum occupant mass is 120kg. The Electric Wheelchair is a battery powered four wheeled vehicle. It consists two Lithium batteries with an off-board battery charger, frame, controller, motors, seat with cushion, back support with cushion, control device (including the battery power indicator, power ON button, power OFF button, horn button, speed indicator, speed-up button, slow-l down button, joystick, charging port), arm supports, two rear wheels, two casters(front wheels), foot support, anti-tip devices, push handle. The wheelchair can easily fold and unfold for transportation or storage.
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    K Number
    K240120
    Device Name
    Merlexi Craft Bariatric series of manual wheelchairs
    Date Cleared
    2024-07-05

    (171 days)

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

    Turbo **Wheelchair **Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Merlexi Craft Bariatric series of manual wheelchairs are intended for use to empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions for which manual wheelchairs are generally prescribed for use. In particular, the Merlexi Craft Bariatric wheelchairs are intended for users up to 425 pounds. They are not for MRI environment use.
    Device Description
    Not Found
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    K Number
    K170701
    Device Name
    GEN_2 and GEN_3 Mechanical Wheelchairs
    Date Cleared
    2017-03-24

    (16 days)

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

    Free **Wheelchair **Mission

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GEN 2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position. The GEN 3 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.
    Device Description
    The GEN 2 mechanical wheelchair is a highly adaptable allpurpose wheelchair created for use in developing countries, while allowing for a healthy, personalized fit. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests. The GEN 3 Mechanical Wheelchair is a folding, non-rigid type wheelchair designed for use over rough terrain in developing countries. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.
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    K Number
    K141691
    Device Name
    GEN_3
    Date Cleared
    2014-12-17

    (176 days)

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

    FREE **WHEELCHAIR **MISSION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GEN_3 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.
    Device Description
    The GEN 3 Mechanical Wheelchair is a folding, non-rigid type wheelchair designed for use over rough terrain in developing countries. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.
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    K Number
    K113713
    Device Name
    GEN_2 MECHANICAL WHEELCHAIR
    Date Cleared
    2012-05-07

    (140 days)

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

    FREE **WHEELCHAIR **MISSION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GEN 2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.
    Device Description
    The GEN 2 mechanical wheelchair is a highly adaptable all-purpose wheelchair created for use in developing countries, while allowing for a healthy, personalized fit. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.
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    K Number
    K103212
    Device Name
    ROUGHRIDER
    Date Cleared
    2011-01-03

    (63 days)

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

    WHIRLWIND **WHEELCHAIR **INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RoughRider is indicated to provide mobility to persons restricted to a seated position. The wheelchait is indicated for a weight capacity of up to 220 lbs.
    Device Description
    The Whirlwind RoughRider® is a user propelled, manually operated folding wheelchair. The Whirlwind RoughRider has not previously been submitted to the FDA for clearance. The Whirlwind RoughRider utilizes carbon steel tubing (STKM 11 AC) that is bent, fastened and/or welded to create a frame. An X-Brace connects the left and right mono frame (single piece side frame design) side frames of the wheelchair together and serves as the mechanism that allows the frame to fold. A set of adjustable axle sockets are attached to each side frame which provide the wheelchair with ability to move the rear wheel position forward and backward to give the user an adjustment as to the center of gravity of the wheelchair. Front casters (hubs and tires) are connected to a fork that is fastened to the front frame of the caster housing. The front casters of the RoughRider are positioned approximately five inches further forward than most wheelchair designs, which gives the user of the RoughRider a very stable ride in terms of forward stability. The RoughRider is intended for use on smooth indoors surfaces and outdoor surfaces which require additional forward stability such as pocked dirt and uneven pavement. The nylon upholstery back and seat meets EN 1021-2: Flammability Testing with Match and Cigarette.
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    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

    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

    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

    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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    K Number
    K040561
    Device Name
    MANUAL WHEELCHAIR SERIES
    Date Cleared
    2004-03-31

    (28 days)

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

    SHANGHAI **WHEELCHAIR **FACTORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Manual Wheelchair Series is to provide mobility to persons limited to a sitting position.
    Device Description
    The Manual Wheelchair Series are manually operated, self or attendant propelled, manual, mechanical wheelchairs. Their intended function and use is to provide mobility to persons limited to a sitting position. The products may also be used as attendant propelled patient transport devices in a health care environment such as hospital, nursing homes, or extended care facilities. The products consist primarily of a metal frame, large rear wheels with hand rims for propelling the chair, and smaller front pivoting casters for steering and turning. There is also an attendant propelled version (Model 0400), which has smaller rear wheels than the others in the series.
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