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510(k) Data Aggregation

    K Number
    K233470
    Device Name
    DEKA LILY
    Manufacturer
    El.En. S.p.A.
    Date Cleared
    2023-12-19

    (55 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K200545
    Why did this record match?
    Device Name :

    DEKA LILY

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

    The LILY device is indicated for muscle conditioning to stimulate healty muscles.

    The device is not intended to be used in conjunction with therapy or treatment of medical disease or medical conditions of any kind.

    The device is intended to be operated by a trained professional who is present to monitor treatment.

    Device Description

    The DEKA LILY device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveforms via electrodes incorporated in an EMS applicator connected to the main unit.

    The delivery of the electrical energy is controlled by a footswitch.

    The DEKA LIL Y is provided with an applicator to perform EMS (Electrical Muscle Stimulation).

    The applicator is provided with two different tips: Large and Medium, used to treat areas having different sizes, which include 3 stainless-steel equidistant electrodes.

    The Applicator is directly applied on the area to be treated and moved by the operator across the skin.

    The overall weight is approximately 62 kg and the sizes 47cm x 56cm x 106cm (L x W x H).

    Electrical requirements: 115V, 50/60Hz, 2300VA.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the DEKA LILY device, based on the provided FDA 510(k) summary:

    Important Note: The provided document is a 510(k) summary for a Powered Muscle Stimulator (DEKA LILY). For this type of device, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily focused on safety and electrical performance to demonstrate substantial equivalence to a predicate device, rather than diagnostic accuracy or clinical efficacy studies that would typically involve AI/ML models. Therefore, many of the questions related to AI/ML model evaluation (e.g., ground truth, expert adjudication, MRMC studies) are not applicable in this context.

    1. Table of Acceptance Criteria and Reported Device Performance

    For the DEKA LILY, acceptance criteria are generally defined by compliance with recognized electrical safety and performance standards for muscle stimulators, and a comparison to a legally marketed predicate device.

    Acceptance Criteria CategorySpecific Criteria/StandardReported Device Performance (DEKA LILY)Comparison to Predicate (Legend Pro DMA)Comment on Acceptance
    Electrical SafetyANSI AAMI ES60601-1CompliantN/A (Standard Compliance)Met
    IEC 60601-1-2 (EMC)CompliantN/A (Standard Compliance)Met
    IEC 60601-2-10CompliantN/A (Standard Compliance)Met
    Patient Leakage Current - Normal ConditionLimit:
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