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510(k) Data Aggregation

    K Number
    K160849
    Date Cleared
    2016-12-15

    (262 days)

    Product Code
    Regulation Number
    890.5500
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The WS(TM) Far-Infrared Therapy Unit, Model: KP-B210, may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains.

    Device Description

    The WSTM Far-Infrared Therapy Unit, Model: KP-B210, is an infrared heating system which delivers 3~25 um Far-infrared energy through Far Infrared (FIR) radiation plate. The device is a non-invasive physiology therapy device and emits topical heat to the human forearm and upper arm for therapeutic applications without direct contact. The model, KP-B210 is a single object without additional assembly which contains an emitter, a user control panel, a power switch and safety distance reminder.

    AI/ML Overview

    This document pertains to a 510(k) premarket notification for a medical device (WSTM Far-Infrared Therapy Unit, Model: KP-B210) and does not describe a study involving an algorithm's performance, human readers, or ground truth establishment in the context of AI. Therefore, I cannot extract the requested information.

    The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (electrical safety, EMC, spectrum, functional certification, usability, and temperature safety tests) and comparing technical specifications. No clinical test data was used to support the decision of substantial equivalence, and there is no mention of an algorithm or AI.

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