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510(k) Data Aggregation

    K Number
    K022175
    Device Name
    P4 PHYSIO
    Manufacturer
    VALMED CORP.
    Date Cleared
    2002-09-09

    (68 days)

    Product Code
    IPF,IPG
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    P4 PHYSIO

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

    Electrical Muscle Stimulator (EMS) devices should only be used under advice from physician or a qualified health professional as adjunctive therapy for the treatment of medical conditions. The intended application is for stimulation of all parts of a body except head and frontal part of the neck. Specific applications include:

    • Relaxation of muscle spasms
    • Prevention or retardation of disuse atrophy;
    • Increasing local blood circulation;
    • Muscle re-education;
    • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis;
    • Maintaining or increasing range of motion of extremities.
    Device Description

    Powered Muscle Stimulator

    AI/ML Overview

    This document indicates a 510(k) clearance for a P4-PHYSIO Powered Muscle Stimulator. The document does not describe acceptance criteria or a study proving that the device meets acceptance criteria. It focuses on the substantial equivalence determination for the device based on its indications for use. Therefore, I cannot provide the requested information from the given text.

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