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510(k) Data Aggregation

    K Number
    K253926

    Validate with FDA (Live)

    Device Name
    Diacore
    Manufacturer
    Date Cleared
    2026-04-10

    (123 days)

    Product Code
    Regulation Number
    890.5850
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K254004

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    Device Name
    VRNT
    Manufacturer
    Date Cleared
    2026-04-10

    (116 days)

    Product Code
    Regulation Number
    890.5800
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253952

    Validate with FDA (Live)

    Date Cleared
    2026-04-07

    (118 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253340

    Validate with FDA (Live)

    Date Cleared
    2026-04-03

    (185 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252386

    Validate with FDA (Live)

    Date Cleared
    2026-04-03

    (246 days)

    Product Code
    Regulation Number
    890.5650
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253076

    Validate with FDA (Live)

    Date Cleared
    2026-04-02

    (191 days)

    Product Code
    Regulation Number
    890.5650
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The K5 Wheelchair is to provide mobility to persons limited to a sitting position.

    Device Description

    The K5 series is a mechanical wheelchair which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests, 2 removable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to manoeuvre the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.

    Main Components:
    Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, rear wheel, hand rim, crossbar, footplates, brake, leg rest.

    The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

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    K Number
    K252893

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-27

    (197 days)

    Product Code
    Regulation Number
    890.5851
    Age Range
    18 - 75
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ExaStim Stimulation System is indicated for the improvement of hand sensation and strength in individuals between 18 and 75 years old who present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury, when used in conjunction with functional task practice.

    Device Description

    The ExaStim® Stimulation System is designed to deliver transcutaneous electrical spinal stimulation for therapeutic use in individuals with incomplete spinal cord injury (SCI). The ExaStim Portable Stimulator is a battery-operated medical device composed of specialized electronics and embedded firmware. It emits stimulation according to parameters configured by the ExaStim Programmer by a clinician.

    The ExaStim Stimulation System consists of the components described in Table 1.

    Part NameDescription
    ReCure® Electrode PadNon-invasive 16-channel multi-electrode array
    ExaStim® Portable StimulatorGenerates and delivers controlled electrical stimulation to the spinal cord and dorsal roots via the ReCure® Electrode Pad based on commands from the ExaStim® Programmer
    ReCure® Stimulation CableConnects the ExaStim® Portable Stimulator to the ReCure Electrode Pad
    ExaStim® Return Electrode CableConnects the return electrodes (i.e., PALS Neurostimulation Electrode) to the ExaStim® Portable Stimulator
    ExaStim® ProgrammerBluetooth‡-enabled mobile digital device preloaded with proprietary ExaStim® Programming Software; includes a charging cable.
    ExaStim® Charging CableCharger used to recharge the battery of the ExaStim Portable Stimulator

    In addition to the components listed above, the system requires two PALS‡ Neurostimulation Electrodes manufactured by Axelgaard, as shown in Table 2 which are not included with the system.

    Part NameCatalog NumberDescription
    PALS‡ Neurostimulation Electrode895240Return electrodes
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    K Number
    K253307

    Validate with FDA (Live)

    Date Cleared
    2026-03-27

    (179 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 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

    This Electric wheelchair is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.

    The Electric wheelchair is composed of frame, motor, controller, lithium battery and seat cushion. The Electric wheelchair is powered by lithium battery which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet when the device is not in use.

    The patient can activate the controller handle (joystick) to control the speed and direction of the Electric wheelchair movement. In addition, when the patient releases the joystick, it will return back to the central position and the Electric wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the Electric wheelchair will be re-energized.

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    K Number
    K253980

    Validate with FDA (Live)

    Date Cleared
    2026-03-27

    (105 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Electrically Powered 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 device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, pedal, battery box and charger.

    Electrically Powered Wheelchair is powered by Li-ion Battery pack (25.55V 10.4Ah*2) with 11.8 km range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use. The materials of frame is Carbon fiber.

    The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

    The max loading of the device is 136KG. Only for one person to sit.

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