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510(k) Data Aggregation

    K Number
    K161502
    Device Name
    MC1 Plus
    Manufacturer
    GENERAL PROJECT S.R.L.
    Date Cleared
    2016-08-16

    (76 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Type
    Special
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K091615
    Why did this record match?
    Reference Devices :

    K091615

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

    The MC1 Plus is indicated for:
    a) Therapeutic Massager:

    1. Provides temporary relief of minor muscle aches and pains;
    2. Relieves muscle spasms;
    3. Temporarily improves local blood circulation;
    4. Temporarily reduces the appearance of cellulite.
      b) Ultrasonic Diathermy:
    5. Relief of pain;
    6. Muscle spasms;
    7. Joint contractures;
    8. NOT for the treatment of malignancies.
    Device Description

    MC1 Plus is a computerized body massager and ultrasound diathermy system. The MC1 Plus is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massager.

    AI/ML Overview

    The provided text is a 510(k) Summary for the General Project MC1 Plus device, a computerized body massager and ultrasound diathermy system. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (MC1, K091615), rather than describing a study with acceptance criteria for a novel device's performance.

    Therefore, the requested information categories (1-7, 9) cannot be fully populated as they pertain to clinical studies designed to establish specific performance metrics against pre-defined acceptance criteria for a new device. This document primarily relies on engineering and electrical safety testing, and performance testing for equivalence to a predicate, not clinical trials to prove device efficacy against acceptance criteria.

    However, based on the provided text, here's what can be extracted and inferred:

    1. A table of acceptance criteria and the reported device performance

    The document does not explicitly state "acceptance criteria" in the context of a clinical study for intended use. Instead, it demonstrates compliance with recognized electrical safety and performance standards, and comparison to a predicate device.

    Acceptance Criteria CategorySpecific Criteria (from standards or predicate comparison)Reported Device Performance (MC1 Plus)
    Electrical SafetyConformance to AAMI/ANSI ES60601-1Conforms
    Electromagnetic Compatibility (EMC)Conformance to IEC 60601-1-2Conforms
    Ultrasonic Physiotherapy Equipment Electrical SafetyConformance to IEC 60601-2-5 (3rd ed.)Conforms
    Tissue Heating PerformanceEquivalence to MC1 (K091615) in terms of increasing tissue temperature to at least 40°C"Testing showed that the MC1 Plus increases tissue temperature as required for ultrasonic diathermy."
    "The two 1 MHz ultrasound transducers can be considered equivalent to the MC1 in terms of heating tissue temperature to at least 40° C."
    Leakage Current (Ground NC)
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