LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K131193
    Device Name
    ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM
    Manufacturer
    TACTILE SYSTEMS TECHNOLOGY INC
    Date Cleared
    2013-06-18

    (53 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K882683
    Why did this record match?
    Device Name :

    ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM

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

    The ACTitouch™ Adaptive Compression Therapy system provides graduated compression in both sustained and intermittent settings for use in:

    • Enhancing venous return .
    • . Reducing venous leg ulcer healing time
    • . Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
    • Treatment of chronic venous insufficiency .
    • Reducing edema due to venous stasis
    • Treatment of lymphedema
    Device Description

    The ACTitouch™ System applies compression to the leg (lower leg, ankle, and foot). It consists of four main parts:

    • . The Compression Sleeve consists of four chambers that inflate with air to apply pressure to the leg. It's simple wrap-around design with hook and loop fasteners means the Compression Sleeve can be fitted to many differently shaped legs and can be applied and removed with ease.
    • The Control Unit fits into the Compression Sleeve during device use. It monitors and . adjusts the air pressure to ensure the correct level of compression is applied to the leg.
    • . The Undersock is designed to draw perspiration and moisture away from the skin and has padding in key areas to provide additional comfort.
    • . The Power Adapter/Charger is used to power the device directly or to charge the battery for ambulatory use.

    The device has two modes of operation: Sustained Compression Mode and Intermittent Pneumatic Compression Mode. Sustained Compression Mode enables the Control Unit to provide accurate and continuously monitored compression levels to the lower limb. Intermittent Pneumatic Compression Mode enables a programmed sequence of cyclical pressures to be applied to the lower limb.

    The ACTitouch™ system features a compliance monitoring feature. An LCD screen is present on the Control Unit, which displays the number of hours the device has been operational in both Sustained Compression Mode and Intermittent Pneumatic Compression Mode.

    AI/ML Overview

    The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a 510(k) summary for the ACTitouch™ Adaptive Compression Therapy system, focusing on its substantial equivalence to a predicate device (Jobst Institute Extremity Pump 7500, K882683).

    While it describes the device, its intended use, and a comparison of technological characteristics, it explicitly states:

    "No comparative testing has been performed between the ACTitouch™ system and Jobst Extremity Pump 7500, as per 807.92 (b) (1.2.3)."

    This indicates that the submission relies on the substantial equivalence argument, rather than presenting new performance data against specific acceptance criteria for this device. Therefore, none of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) can be extracted from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1