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510(k) Data Aggregation

    K Number
    K020464
    Device Name
    SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646
    Manufacturer
    ROLOR ELECTRONICS CORP.
    Date Cleared
    2002-09-17

    (217 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646

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

    Temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.

    Device Description

    Sanidad Far-Infrared Mini Lamp, FI-3646

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the Sanidad Far-Infrared Mini Lamp, FI-3646. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory classifications, general controls, and compliance requirements, but it does not detail any performance studies conducted by the manufacturer for this specific device.

    Therefore, I cannot provide the requested information based on the provided text. The document is strictly a regulatory approval notice, not a scientific study report.

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