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510(k) Data Aggregation

    K Number
    K201958
    Device Name
    ETD Family of Electrotherapy Devices
    Manufacturer
    TheraSigma, LLC
    Date Cleared
    2020-08-04

    (21 days)

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

    ETD Family of Electrotherapy Devices

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

    ETD100 TENS Device: TENS Mode: Transcutaneous Electrical Nerve Stimulation for Pain Relief: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
    ETD200 NMES Device: NMES Mode: Neuromuscular Electrical Stimulation: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding muscle disuse atrophy, muscle reeducation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
    ETD300 TENS and NMES Combination Device: TENS Mode: Transcutaneous Electrical Nerve Stimulation for Pain Relief: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. NMES Mode: Neuromuscular Electrical Stimulation: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding muscle disuse atrophy, muscle reeducation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
    ETD400 IFCS Device (IFCS = Interferential Current Stimulation): IFCS Mode: Interferential Current Stimulation: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
    ETD500 TENS and IFCS Combination Device: TENS Mode:Transcutaneous Electrical Nerve Stimulation for Pain Relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. IFCS Mode: Interferential Current Simulation: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
    ETD600 NMES and IFCS Combination Device: NMES Mode: Neuromuscular Electrical Stimulation: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding muscle disuse atrophy, muscle reeducation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. IFCS Mode: Interferential Current Simulation: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
    ETD700 TENS and NMES and IFCS Combination Device: TENS Mode: Transcutaneous Electrical Nerve Stimulation for Pain Relief. Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. NMES Mode: Neuromuscular Electrical Stimulation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding muscle disuse atrophy, muscle reeducation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. IFCS Mode: Interferential Current Simulation. Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA clearance letter for a family of electrotherapy devices (ETD Family: Models ETD100, ETD200, ETD300, ETD400, ETD500, ETD600, and ETD700). It establishes substantial equivalence to a predicate device but does not contain any information regarding acceptance criteria, device performance, or details of a study that proves the device meets specific criteria.

    The letter focuses on:

    • Acknowledging the 510(k) premarket notification.
    • Stating the substantial equivalence determination.
    • Outlining regulatory requirements for the device (registration, labeling, good manufacturing practice, etc.).
    • Listing the indications for use for each model (TENS, NMES, IFCS modes).

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications from the provided text.

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