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510(k) Data Aggregation

    K Number
    K252140
    Device Name
    Heylo™ System
    Manufacturer
    Date Cleared
    2025-10-06

    (90 days)

    Product Code
    Regulation Number
    876.5900
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Heylo™ System is indicated to allow detection of ostomy appliance leakage for people with an ileostomy or colostomy, giving them an opportunity to take preventative measures. Heylo™ System is comprised of a protective adhesive barrier with integrated sensors that detect occurrences of leakage of output from the wearer's stoma and a transmitter that translates leakage data and sends notifications to the user's Heylo™ app. Heylo™ System and its components are for individuals with an ostomy 12 years and older.

    Device Description

    Heylo™ System is a leakage notification system designed to monitor for leakage of stoma output in patients with an ileostomy or colostomy. Heylo™ System is comprised of a protective adhesive barrier with integrated sensors that detect occurrences of leakage of output and a transmitter that translates leakage data and sends notifications to the user's Heylo App.

    The Heylo™ System is considered an accessory to the ostomy bag/pouch. It is intended to be used together with an ostomy barrier (synonymous with ostomy pouch, ostomy baseplate and bag) and designed for compatibility with most baseplates and supporting products. It can be worn wherever patients normally wear their ostomy appliance.

    AI/ML Overview

    N/A

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