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510(k) Data Aggregation

    K Number
    K073361
    Device Name
    MUSCLE PAIN DEVICE (MPD)
    Manufacturer
    STEVENS PROOF OF CONCEPT, INC.
    Date Cleared
    2008-03-18

    (109 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
      1. Relaxation of muscle spasms.
      1. Muscle re-education.
      1. Maintaining or increasing range of motion.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Muscle Device (MD)." This document confirms that the device is substantially equivalent to a legally marketed predicate device.

    However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any statistical details about a study to prove the device meets acceptance criteria. It primarily focuses on the regulatory clearance and compliance requirements.

    Therefore, I cannot extract the requested information from this document.

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