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510(k) Data Aggregation

    K Number
    K092222
    Device Name
    THERMAPULSE
    Manufacturer
    PALOMAR MEDICAL PRODUCTS, INC.
    Date Cleared
    2009-08-20

    (28 days)

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

    THERMAPULSE

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

    Power settings in the range of 5-50 Watts is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature 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 the relaxation of muscles. In addition, the ThermaPulse may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Palomar Medical Technologies Inc. ThermaPulse™ device, an infrared lamp. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) summary or the original submission itself, which are not provided here.

    Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on regulatory approval and substantial equivalence to a predicate device.

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