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510(k) Data Aggregation

    K Number
    K232966
    Device Name
    FISIOWARM 7.0
    Manufacturer
    Golden Star Srl
    Date Cleared
    2024-12-26

    (462 days)

    Product Code
    PBX
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K162828
    Why did this record match?
    Applicant Name (Manufacturer) :

    Golden Star Srl

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

    FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The massage devices are intended to provide a temporary reduction in the appearance of cellulite.

    Device Description

    FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are active and therapeutic medical devices that perform their function by releasing energy to the human body.

    AI/ML Overview

    The provided text is a 510(k) summary for the medical device Fisiowarm 7.0. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device performance study (e.g., diagnostic accuracy, reader performance).

    The performance testing mentioned in the document is for electrical safety, electromagnetic compatibility, and a comparative thermal test on human skin to verify energy transfer, not related to an AI/ML device's diagnostic or analytical performance.

    Therefore, I cannot provide the requested information from the given text as it does not pertain to an AI/ML-driven medical device and its associated performance study.

    The document covers:

    • Device Name: Fisiowarm 7.0
    • Regulation Number: 21 CFR 878.4400 (Electrosurgical Cutting And Coagulation Device And Accessories)
    • Product Code: PBX
    • Intended Use: Topical heating to elevate tissue temperature for the treatment of pain, muscle spasms, increased local circulation, and temporary reduction in cellulite appearance.
    • Predicate Device: Winback Back 3SE (K162828)
    • Performance Testing: Electrical compliance (EN 60601-1, EN 60601-1-2) and tissue testing to compare thermal spread. This is essentially showing the device performs its physical function (heating) comparably to the predicate.
    • No mention of AI/ML components or studies measuring diagnostic/analytical performance.
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