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510(k) Data Aggregation

    K Number
    K190976
    Device Name
    Radial Medical Compression System
    Date Cleared
    2019-07-12

    (88 days)

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

    Radial Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Radial Medical Cirvo Compression System is indicated for use in: - Preventing deep vein thrombosis (DVT) - Enhancing blood circulation - Diminishing post-operative pain and swelling - Reducing wound healing time - Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers - Treatment of chronic venous insufficiency - Reducing edema
    Device Description
    The Cirvo Compression System is a light-weight, mobile, sequential compression device (SCD) placed around the calf that sequentially compresses the calf to augment blood flow. SCD's are used in both the hospital and home setting. most commonly to prevent deep vein thrombosis (DVT), heal venous leg ulcers (VLU) and reduce swelling. The Cirvo Compression System includes three components: the Cirvo sequential compression device, an AC charger and a smart device app. The Cirvo compression unit generates compression cvcles using a small motor to sequentially cycle the compression unit on the calf. The Cirvo sequential compression device is placed around the lower leg using a detachable shin guard with self-aligning magnets, with the padded compression unit aligned on the calf. Proper fitting is achieved by adjusting a pair of hook and loop straps. The Cirvo compression system continuously monitors and maintains the prescribed compression therapy, records the duration of therapy session as well as compliance with the prescribed therapy. Therapy can be initiated and stopped using either the app interface on a smart device or using the capacitive touch sensor on the compression unit. Patients can track their progress with the app and can opt in to have text reminders sent to reinforce compliance with their therapy and notifications sent to their physician. All data is saved and transmitted using high-level, AES-128 encryption.
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    K Number
    K181651
    Device Name
    Radial Medical Compression System
    Date Cleared
    2018-10-12

    (112 days)

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

    Radial Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Radial Medical Compression System is indicated for use in: - Preventing deep vein thrombosis (DVT) - Enhancing blood circulation - Diminishing post-operative pain and swelling - Reducing wound healing time - Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers - Treatment of chronic venous insufficiency - Reducing edema
    Device Description
    The Radial Medical Compression System (RMCS) is a light weight, mobile, sequential compression device (SCD) placed around the lower leg. The device is designed to provide sequential compression to the calf to augment blood flow. The system includes three components: the Cirvo sequential compression device, an inductive charging cradle and a smart device app (i.e. tablet or smartphone). The RMCS records the amount and duration of compression received during a therapy session as well as compliance with the prescribed therapy. Identified patient data, and compiled, de-identified data will be shared with the treating physician to facilitate clinical decision making. The Cirvo uses a mechanical system to sequentially compress the leg utilizing four tension zones tensioned in series. A circumferential sleeve of polyester material is placed around the calf, held in place using hook and loop straps. During the compression cycle, a reduction in the effective circumference of the sleeve exerts a radially inward force on the calf. The device has a compression cycle time of 6 seconds and a physician-determined dwell time between compression cycles. The range of compression cycle pressures of the Cirvo is 40-60 mmHg.
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