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510(k) Data Aggregation

    K Number
    K130691
    Device Name
    ELECTROTHERAPY DEVICE (COMBO UNIT)
    Manufacturer
    GUANGZHOU FINECURE MEDICAL EQUIPMENT CO.,LTD
    Date Cleared
    2013-12-20

    (282 days)

    Product Code
    IPF,GZJ,LIH
    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

    TENS stands for Transcutaneous Electrical Nerve Stimulation. The device TENS system is used to provide Symptomatic relief of chronic intractable pain, Post traumatic pain and Post surgical pain.

    EMS stands for Electrical Neuromuscular Stimulator. The device EMS system is indicated for:

      1. Relaxation of muscle spasm.
      1. Increase of local blood flow circulation
      1. Prevention or retardation of disuse atrophy
      1. Muscle re-education
      1. Maintaining or increasing range of motion.
    1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

    IF stands for Interferential Stimulation. The device IF system is indicated for Symptomatic relief of chronic intractable pain, Post traumatic pain and Post surgical pain.

    Device Description

    Electrotherapy Device (Combo Unit) Model 9612

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter for an Electrotherapy Device (Combo Unit) Model 9612. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use (TENS, EMS, and IF systems). It outlines regulatory requirements and general information for the manufacturer but does not include any performance data, clinical study details, or acceptance criteria related to a specific product performance evaluation.

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