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510(k) Data Aggregation

    K Number
    K220529
    Device Name
    Merits P335 Powered Wheelchair
    Manufacturer
    Merits Health Products Co., LTD.
    Date Cleared
    2022-03-18

    (22 days)

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

    Merits Health Products Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merits P335 Powered Wheelchair is intended to provide indoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair. The Merits P335 Powered Wheelchair is to provide indoor and outdoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.
    Device Description
    The Merits P335 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the PG power wheelchair R-net 120 amp controller. The user interface is a joystick. P335 is powered by two 12 VDC 60ah batteries. The batteries are charged by 6A off-board charger connect with 3-pin Microphone Connector to charging socket on joystick. The approximate driving range on fully charged batteries is up to 30km (19mi). The chair frame is a welded steel construction and includes two front drive wheels with drive units (including motor, gear, and brake), batteries and rear pivoting casters. Depending on users' needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the wheelchair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick. The device is equipped with a Power Seating System consists of a power tilt unit, a power recline module and an optional power elevating seat module. The tilt, reclining and elevating systems are actuated by 24V DC motorized linear actuator. The tilt system includes one motorized linear actuator caused the seat frame to shift forward. This enhances stability since the center of gravity is kept substantially in place while the user is tilting. The recline system include one motorized linear actuator change the position of the backrest with respect to the seat pan. The optional elevating seat module use one motorized linear actuator which allows the user to elevate the seat pan for easy accessing things stored in higher places. The upholstery of the device complies with ISO 7176-16:2012: Wheelchairs -- Part 16: Resistance to ignition of postural support devices. The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
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    K Number
    K142912
    Device Name
    Merits Yoga Power Scooter, S542
    Manufacturer
    MERITS HEALTH PRODUCTS CO., LTD.
    Date Cleared
    2015-06-23

    (260 days)

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

    MERITS HEALTH PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merits Yoga Power Scooter, S542, is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
    Device Description
    The Merits Yoga Power Scooter, S542, is battery powered, rear transaxle driven and is controlled by the PG S-Drive 45amp controller. The user interface is a wig-wag control lever and a speed knob on the control panel. S542 is powered by one 12 VDC 11.5Ah battery. The batteries are charged by 4.3A off-board charger connect with 3-pin Microphone Connector to charging socket on the rear shroud. The approximate driving range on fully charged batteries is up to 18km (11.3mi). The scooter frame is a welded aluminum construction and includes 2 rear wheels with drive units (including motor, gear box, and brake), a removable battery pack, a front wheel set which consists of 2 wheels for better stability and a tiller to control its turning direction. When the user activates the wig-wag control lever, the controller receives a signal to release the brakes. With the brakes released, the scooter is allowed to move forwards or backwards. When the user releases the control lever, the scooter slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the control lever. The frame is designed to be foldable for easy storage and transportation. For safety reason, this solenoid electromechanical brake is designed as normal close type. In case of the brake or electrical failure, the brake shoe will re-engage automatically to prevent the movement of the scooter. The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices. The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
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    K Number
    K142162
    Device Name
    MERITS TRANSFORMER POWER SCOOTER, S941
    Manufacturer
    MERITS HEALTH PRODUCTS CO., LTD.
    Date Cleared
    2015-05-01

    (268 days)

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

    MERITS HEALTH PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merits Transformer Power Scooter, S941, is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
    Device Description
    The Merits Transformer Power Scooter, S941, is battery powered, rear transaxle driven and is controlled by the Dynamic Rhino-2 120amp controller. The user interface is a throttle lever and control buttons on the control panel. S941 is powered by two 12 VDC 50ah (22NF) batteries. The batteries are charged by 5A off-board charger connect with 3-pin Microphone Connector to charging socket on Tiller. The approximate driving range on fully charged batteries is up to 40km (25mi). The scooter frame is a welded steel construction and includes 2 rear wheels with drive units (including motor, gear box, and brake), batteries, 2 front wheels and a tiller to control its turning direction. When the user activates the throttle lever, the controller receives a signal to release the brakes. With the brakes released, the scooter is allowed to move forwards or backwards. When the user releases the throttle lever, the scooter slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the throttle lever. The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices. The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
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    K Number
    K122357
    Device Name
    MERITS MODEL P322FWD POWERED WHEELCHAIR
    Manufacturer
    MERITS HEALTH PRODUCTS CO., LTD.
    Date Cleared
    2013-01-09

    (159 days)

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

    MERITS HEALTH PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merits Model P322 Powered Wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
    Device Description
    Model P322 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the PG power wheelchair VR-2 50amp controller. The user interface is a joystick. P322 is powered by two 12 VDC 34ah (U1) batteries. The batteries are charged by 4A off-board charger connect with 3-pin Microphone Connector to charging socket on joystick. The approximate driving range on fully charged batteries is up to 28km (18mi). The chair frame is a rived nut and welded steel construction and includes two front drive wheels with drive units (including motor, gear, brake), batteries and rear pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the wheelchair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick. The upholstery of the device complies with EN 1021-1/-2:2006: Furniture: Assessment of the ignitability of upholstered furniture: Ignition source: Smouldering cigarette/ Match flame equivalent The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
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    K Number
    K113577
    Device Name
    MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR
    Manufacturer
    MERITS HEALTH PRODUCTS CO., LTD.
    Date Cleared
    2012-05-08

    (155 days)

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

    MERITS HEALTH PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merits Model R series Positioning System for Powered Wheelchair is intended for people using a powered wheelchair and requiring positional change. Its intended function and use is to aid in the pressure relief to persons confined to a powered wheelchair, by way of tilt and reclining seat back.
    Device Description
    The R Series Positioning System for Powered Wheelchair is designed for use with power wheelchairs. The R Series Positioning System for Powered Wheelchair use the Merits Model P323 Power Wheelchair as the base unit for the tilting and reclining System. The Positioning System and base unit is to be sold together. Model P323 Powered Wheelchair is battery powered, center wheel motor driven and is controlled by the PG power wheelchair VR-2 60amp controller. The user interface is a joystick. P323 is powered by two 12 VDC 64ah batteries. The batteries are charged by 5A off-board charger connect with 3-pin Microphone Connector to charging socket on joystick. The approximate driving range on fully charged batteries is up to 38km (24mi). The chair frame is a rived nut and welded steel construction and includes two center drive wheels with drive units (including motor, gear, brake), batteries and front and rear pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the wheelchair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick. The intended function of the R Series Positioning System for Powered Wheelchair is to aid in the pressure relief of persons confined to a wheelchair, by providing a method of tilting the seat and reclining the seat back. The R series Positioning System consists of tilt, recline and shear reduction power seat modules. The tilting and reclining systems are separate modules and are independent of each other. As such, they will be offered as either a complete tilt/recline system, or as a separate tilt system or reclining system depending upon the user' needs. The tilting and reclining systems are actuated by 24V DC motorized linear actuator. The tilt system include one motorized linear actuator (Manufacturer: Moteck / Model: FD-24-A4-323) causes the seat frame to shift forward. This enhances stability since the center of gravity is kept substantially in plane while the user is tiliting. The recline system include one motorized linear actuator (Manufacturer: Moteck / Model: FD-24-A4-278) change the position of the backrest with respect to the seat pan. The shear reduction module works with recline function to reduce the shear movement between the user and the backress The reclining system also includes a movable leg rest feature. There two basic models included in the R Series Positioning System. They are Model R153(tilt) and R154(tilt +reclining). The upholstery of the device complies with EN 1021-1/-2:2006: Furniture: Assessment of the ignitability of upholstered furniture: Ignition annuce: Smouldering cigarette/ Match flame equivalent. The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
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    K Number
    K092859
    Device Name
    MERITS MODEL N SERIES NEBULIZER COMPRESSORS
    Manufacturer
    MERITS HEALTH PRODUCTS CO., LTD.
    Date Cleared
    2010-07-02

    (288 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERITS HEALTH PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merits Model N Series Nebulizer Compressors are AC-powered air compressors intended to provide a source of compressed air for medical purposes for use in home health care. These devices are used in conjunction with a pneumatic nebulizers to produce fine aerosol mists of medication for respiratory therapy, for both children and adults suffering from respiratory disorders such as asthma, allergies, etc.
    Device Description
    The Merits Model N Series Nebulizer Compressors consist of AC powered piston-type compressors that generates compressed air. They are small, lightweight and designed for convenience. The piston-type compressor is housed in a plastic cabinet with rubber bumpers. The motor driven piston compressor is connected with a power cord and a switch. The devices contain no microprocessors or other electronic components. They operate from 115VAC/60Hz. Each of them is supplied with tubing, a nebulizer kit and several replaceable filters. Model N281 and N282 are identical in specifications and components. The only difference is they use different cabinets which are different in size and shape. When using, the compressor is placed on a flat surface. Air delivery tubing and a nebulizer kit are connected to the outlet hose barb. The air passes the replaceable filter is compressed and delivered to the nebulizer kit through the tubing.
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    K Number
    K091716
    Device Name
    MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY
    Manufacturer
    MERITS HEALTH PRODUCTS CO., LTD.
    Date Cleared
    2010-04-02

    (296 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERITS HEALTH PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oxygen Concentrators with the Oxygen Filling accessory are indicated to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended for life support nor does it provide any patient monitoring capabilities.
    Device Description
    The Profill Q601 series oxygen filling machines are prescription devices designed for use in home by patients that require supplemental oxygen. It is intended to pressurize oxygen from an oxygen concentrator to fill gas cylinders for the patient's personal ambulatory use. It is not intended for life support nor does it provide any patient monitoring capabilities. The device consists of a compressor module and a portable oxygen cylinder with a specially adapted cylinder fitting. It is compatible with available standard oxygen concentrators as the source of oxygen. The oxygen generated by the oxygen concentrator is inducted into a buffer tank. Then it flows to the compressor where the oxygen is pressurized and filled into the cylinder. The devices are not sold or labeled as sterile.
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    K Number
    K073110
    Device Name
    MERITS E600 SERIES STAIR LIFT
    Manufacturer
    MERITS HEALTH PRODUCTS CO., LTD.
    Date Cleared
    2008-02-06

    (93 days)

    Product Code
    ILK
    Regulation Number
    890.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERITS HEALTH PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merits E600 Series Stair Lift System is a powered patient transport, also commonly known as a Stairway Chairlift, or Stairlift. It is a motorized device intended for medical purposes to assist transfers of patients, or mobility-impaired persons, up and down flights of stairs.
    Device Description
    The Merits E600 Series Stair Lift basically consists of an upholstered chair assembly, a truck assembly, and a maximum 16 feet track. The chair and truck assemblies constitute the platform moving up and down along the inclined track. The entire lift is installed in either side of the indoor stairway in a private residence. All models share the same specifications such as driving means and safeties other than the power source. The Model E600 uses the AC power as its power source while the Model E601 employs the batteries and chargers. The operation of the lift is controlled by a momentary rocker control under one armrest and two infrared remote controls. The move of the lift will stop immediately when the button or switch of the controls is released.
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    K Number
    K073513
    Device Name
    MERITS E700 PORCE LIFT
    Manufacturer
    MERITS HEALTH PRODUCTS CO., LTD.
    Date Cleared
    2008-01-14

    (31 days)

    Product Code
    ING
    Regulation Number
    890.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERITS HEALTH PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merits E700 Porch Lift System is a wheelchair elevator, also commonly known as a vertical platform lift. It is a motorized device intended to mechanically transport an individual with mobility disability, either in a wheelchair device or ambulatory, from one level to another in a private residence.
    Device Description
    The Merits E700 Porch Lift basically consists of a platform assembly and a driving machine case assembly. The platform assembly vertically moves along a guide rail welded to the driving machine case assembly. The sides of the platform assembly are guarded by sheet steel plates. The lower landing side of the platform is equipped with an automatic folding ramp to not only offer easy access to the platform but also to prevent the mobility device rolling off the edges. The ramp will be automatically folded up as the lift begins to move upward and remain in elevated position until the platform returns to the lower landing. The underside of the platform is equipped with a safety plate to stop the motion when the platform is obstructed in the downward direction. The driving machine case assembly contains all necessary operation systems in the case. The operation of the lift is controlled by the platform operating panel and the call/send controls. These control devices are designed by means of continuous pressure type, which stop the lift immediately when the switch is released. The Merits E700 Porch Lift is using AC power as its power source.
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    K Number
    K053490
    Device Name
    MERITS HEALTH PRODUCTS PORTABLE NEBULIZER
    Manufacturer
    MERITS HEALTH PRODUCTS CO., LTD.
    Date Cleared
    2006-07-24

    (221 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERITS HEALTH PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merits Health Products Portable Nebulizers are designed to deliver the prescribed liquid medication to treat patients' respiratory disorders, such as asthma, allergies, and bronchitis. The device is not intended for life support nor does it provide any patient monitoring capabilities.
    Device Description
    The Merits Health Products Portable Nebulizer system consists of a DC powered piston-type compressor that generates compressed air. Small, lightweight and designed for convenience, the Merits device offers the user a choice of running off of AC power via a universal adapter or DC power via an option 12 volt auto adapter or an optional rechargeable battery pack. The device consists of a motor driven piston compressor, a printed circuit board and a switch. The circuit board does not incorporate a microprocessor but serves as a means to prevent double feed of power. The circuit board is not a part of the charging circuit for the battery pack. The nebulizer, which employs a venturi effect to convert the medication into a fine aerosol mist, is used snapped directly onto the compressor outlet. The nebulizer is designed for single patient use, specifically for use only with the Merits compressor. Use different kinds of compressors may impair the performance.
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