Search Filters

Search Results

Found 2364 results

510(k) Data Aggregation

    K Number
    K251531
    Manufacturer
    Date Cleared
    2025-10-30

    (164 days)

    Product Code
    Regulation Number
    890.5650
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K253150
    Date Cleared
    2025-10-24

    (29 days)

    Product Code
    Regulation Number
    890.5650
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K244041
    Date Cleared
    2025-10-07

    (281 days)

    Product Code
    Regulation Number
    890.5860
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended for use only in adult patients.

    Therapeutic Ultrasound
    Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

    1. Pain relief, muscle spasms and joint contractures.
    2. Relief of pain, muscle spasms and joint contractures that may be associated with:
      • Adhesive capsulitis
      • Bursitis with slight calcification
      • Myositis
      • Soft tissue injuries
      • Shortened tendons due to past injuries and scar tissues
    3. Relief of sub-chronic, chronic pain and joint contractures resulting from:
      • Capsular tightness
      • Capsular scarring

    For TENS, Interferential, premodulated (IFC), NMS and Microcurrent:

    1. Symptomatic relief of chronic intractable pain
    2. Post-traumatic acute pain
    3. Post-surgical acute pain

    Additionally for NMS, NMS Burst, Hi-Volt and Russian:

    1. Relaxation of Muscle spasms
    2. Prevention or retardation of disuse atrophy
    3. Increasing local blood circulation
    4. Muscle re-education
    5. Maintaining or increasing range of motion
    6. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

    For DC Continuous Mode

    1. Relaxation of muscle spasm
    Device Description

    The Ultrasound Therapy Workstation (model: XMS-UET2) is an AC-powered device designed to use electrical stimulation and therapeutic ultrasound. Key features include ultrasound output and electrical stimulation output. This device is intended for use in healthcare environments such as hospitals, rehabilitation centers, community health service centers, and clinics.
    The device has a color touchscreen display and a control knob with light ring. The screen display shows system information to the user. Both display screen and control knob can assist the user in selecting or adjusting parameters. All controls and indicators are controlled by software.
    Three non-invasive therapeutic methods are available: electrotherapy, ultrasound therapy and combination therapy (ultrasound plus electrical stimulation). For each method, the device is configured with protocols and manual operation, which can facilitate users to choose pre-set protocols or adjust parameters to suit individual needs.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K251565
    Date Cleared
    2025-10-06

    (137 days)

    Product Code
    Regulation Number
    890.3860
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K252502
    Date Cleared
    2025-10-06

    (59 days)

    Product Code
    Regulation Number
    890.3800
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K252517
    Date Cleared
    2025-10-03

    (53 days)

    Product Code
    Regulation Number
    890.3850
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is 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

    Not Found

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K252428
    Date Cleared
    2025-09-18

    (48 days)

    Product Code
    Regulation Number
    890.3860
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis 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

    The Electric wheelchair, Model P2, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-Ion battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.

    The control system, including the controller handle (joystick), is equipped on the control board that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.

    The electric wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K251905
    Date Cleared
    2025-09-18

    (90 days)

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

    The Normatec Elite Hip is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

    Device Description

    The Normatec Elite Hip is a powered inflatable tube massager (Product Code "IRP"). It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by the use of an inflatable pressure cuff. The devices are to be used by people who are in good health. The devices are charged and powered from an external compliant power supply. In addition, powered by an internal IEC 62133-2 compliant lithium-ion battery.

    The user interface on the Normatec Elite Hip is a series of buttons with a small display screen to display the treatment time, pressure level, zone boost number. The user interface provides for:

    • Starting and stopping the massage treatment;
    • Adjusting time and intensity (pressure) of the treatment;
    • Selection of the zone to boost the pressure

    In addition to the user interface on the devices, the proposed devices have Bluetooth capability that allows the use of a NormaTec app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K251623
    Date Cleared
    2025-09-17

    (112 days)

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

    The Air compression therapy device(K1002K1102/K1006/K1007/K1008/K1061 ) is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

    Device Description

    Not Found

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 237