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510(k) Data Aggregation

    K Number
    K193288
    Device Name
    Koya Ripple
    Manufacturer
    Koya, Inc.
    Date Cleared
    2020-06-16

    (202 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Koya, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Koya Dayspring system is a prescription only wearable compression system that is intended for use in a clinic or home setting by medical professionals and patients who are under medical supervision for the following: - Lymphedema - Primary lymphedema - Post mastectomy edema - Edema following trauma and sports injuries - Post immobilization edema - Venous insufficiency - Reducing wound healing time The Koya Dayspring system is developed on a wearable compression technology platform, which is designed to provide mobility for patients.
    Device Description
    The Koya Dayspring™ system is powered by an active smart compression technology that is calibrated, instant-acting, and silent. This technology uses a Nickel Titanium (Ni-Ti) shape-memory alloy programmed by a controller system. A disposable stockinette is worn as an accessory under the device to prevent direct patient contact with the device is wrapped around the patient's arm so that the device fits snugly. The device has up to 16 independently controlled sections in each arm. The controller can be programmed to provide sequential compression therapy to the affected area over a range of 0-100 mmHg. The device is powered by a rechargeable Lithium-ion battery pack. The device was developed to provide patients with untethered access and a functional range of motion and mobility while treating chronic lymphedema.
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