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510(k) Data Aggregation

    K Number
    K003916
    Device Name
    DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM
    Manufacturer
    SCANDIA MANUFACTURING LTD.
    Date Cleared
    2002-04-15

    (482 days)

    Product Code
    IMB
    Regulation Number
    890.5250
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCANDIA MANUFACTURING LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
      1. To temporarily increase local blood circulation.
      1. To temporarily reduce minor muscular pain.
      1. To help induce relaxation of muscles.
      1. To treat arthritis and fibrosis.
      1. To provide topical heating.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer the request as the document does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for the DermaMED System, which states that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use. It does not include details on specific device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

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