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510(k) Data Aggregation

    K Number
    K993684
    Device Name
    SPINAL PAD
    Manufacturer
    BIOSCAN, INC.
    Date Cleared
    2000-07-19

    (261 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 :

    SPINAL PAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Use wherever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional
    • Provides temporary relief of minor aches and pains in muscles and joints
    • Aids in the relaxation of muscles
    • Helps provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief
    • Provides a temporary increase in local blood circulation
    Device Description

    Spinal Pad

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a device called "Spinal Pad" and outlines the indications for use. It does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

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