LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K162987
    Device Name
    FA100 SCCD (Sequential Continuous Contraction Device)
    Manufacturer
    FlowAid Medical Technologies, Corp
    Date Cleared
    2017-02-14

    (110 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K112348,K031017,K133638,K050046
    Why did this record match?
    Reference Devices :

    K112348, K031017, K133638

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

    The FA100 SCCD is indicated for use in:

    • Increasing local blood circulation,
    • . Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
    • Preventing or retarding disuse atrophy
    • Edema reduction
    Device Description

    The FA100 SCCD is a portable, battery powered, hand-held 4-channel electrical stimulator (single unit) intended to provide continuous, sequential stimulation of the calf muscles. The FA100 SCCD designed to be user friendly and simple to use, with a large liquid crystal display (LCD) screen that displays the treatment mode currently in use and the selected intensity level for the patient to select a comfortable therapy session as recommended by the patient's healthcare provider.
    The FA100 SCCD system provides three preset treatment programs, which enable the patient to choose among three pulse frequencies:

      1. 4 Hz (program AA)
      1. 9 Hz (program VE - the default setting of the device)
      1. 14 Hz (program PA)
        Pulse frequency is the only difference between the three programs and is selected for patient comfort during the treatment as recommended by the patient's healthcare provider. The stimulation provided by the FA100 SCCD rotates in a continuous, sequential pattern through the four channels. The rotation through the channels is directly related to the frequency setting, i.e., slowest for the 4 Hz program and fastest for the 14 Hz program. All programs effectively contract the muscles and increase blood flow. The only other parameter that can be varied is the stimulus intensity, which is set by the user to achieve the maximum tolerable contraction. Otherwise, the pulse shape (rectangular, symmetrical, bi-phasic), pulse width (500 µsec), and stimulation pattern (sequential channel activation) are the same for all three programs.
    AI/ML Overview

    The provided document is a 510(k) Summary for the FlowAid Medical Technologies, Corp. FA100 SCCD (Sequential Continuous Contraction Device). This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not detail specific acceptance criteria or an explicit study proving the device meets those criteria in the typical sense of a diagnostic or screening algorithm. Instead, the "acceptance criteria" are implied by the performance standards for powered muscle stimulators and the "study" is a clinical study supporting the device's indications for use.

    Here's an attempt to extract the requested information based on the provided text, while acknowledging that some aspects (like expert ground truth and MRMC studies) are not applicable to this type of device submission.

    Acceptance Criteria and Reported Device Performance

    The "acceptance criteria" are implied by the electrical and functional specifications that demonstrate substantial equivalence to legally marketed powered muscle stimulators and the successful results of a clinical study for specific indications.

    Criteria CategoryAcceptance Criteria (Implied)Reported Device Performance
    Safety StandardsCompliance with relevant electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and specific nerve/muscle stimulator safety (IEC 60601-2-10) standards.FA100 SCCD successfully passed all testing in accordance with internal requirements, national, and international standards, including IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10.
    Software ValidationCompliance with software validation standards (IEC 62304).FA100 SCCD successfully passed software validation per IEC 62304:2006.
    Home Health EnvironmentCompliance with standards for equipment used in home health (IEC 60601-1-11).FA100 SCCD successfully passed electrical testing per IEC 60601-1-11:2010.
    Device FunctionalityDevice specifications (waveform, output voltage, current, pulse width, frequency, phase charge, current/power density) are within acceptable ranges for NMES devices.All output specifications (e.g., max output voltage 80V, max output current 160mA, pulse width 500µsec, frequencies 4, 9, 14 Hz, max phase charge 8µC, max current density 6.4 mA/cm²) were found to be within acceptable ranges for NMES devices and comparable to or safer than predicate/other legally marketed devices.
    Indications for Use (Edema Reduction)Demonstrate effectiveness in reducing leg circumference for patients with chronic venous insufficiency.A clinical study showed that the average circumference at both the ankle (21.9% decrease, p
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1