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510(k) Data Aggregation

    K Number
    K202159
    Device Name
    actiTENS
    Manufacturer
    Sublimed
    Date Cleared
    2020-12-22

    (141 days)

    Product Code
    GZJ,IPF,NGX,NYN
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K070807,K182203
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    actiTENS is intended to be used as:

    • Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:
    • Symptomatic relief and management of chronic, intractable pain
    • Adjunctive treatment for post-surgical and post-trauma acute pain
    • Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
    • Relief of pain associated with arthritis
      Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12 and P13 correspond to TENS mode.
    • Electrical Muscle Stimulation (EMS), used for the following indications:
    • Temporary relaxation of muscle spasms
    • Prevent or retard disuse atrophy
    • Increase of local blood flow in the treatment area
    • Re-educate muscles
    • Maintain or increase the range of motion
    • Prevention of venous thrombosis of the calf muscles immediately after surgery
      Program P9 corresponds to EMS mode.
    Device Description

    actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people ages 22 and older.
    The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.
    The impulse generator is delivered with a separate cradle which allows safely recharging its nonremovable battery.
    The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.
    The actiTENS is controlled via a downloadable mobile app for iPhone which allows the comfortable and simple selection of the adequate stimulation program.
    The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance data for the actiTENS device, primarily focusing on its substantial equivalence to a predicate device (JKH Stimulator Plus - K182203).

    Here's the breakdown of the information requested:

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

    The document does not explicitly present a "table of acceptance criteria" in the format of a requirement with a corresponding "reported device performance" that unequivocally meets that criterion for clinical efficacy or specific diagnostic accuracy. Instead, it demonstrates substantial equivalence to a predicate device by comparing technological characteristics and performance metrics. The underlying acceptance criterion for this 510(k) submission is that the device is "as safe and effective as the predicate device."

    The comparison table (Table 1: Comparison of actiTENS with JKH Stimulator Plus (K182203) and Table 2: Comparison of actiTENS with JKH Stimulator Plus (K182203) with regards to TENS and EMS performance) serves as the primary evidence. Here's a summary derived from those tables and surrounding text:

    Acceptance Criterion (Implicitly based on Predicate)Reported actiTENS Performance
    Indications for Use (TENS)Symptomatic relief and management of chronic, intractable pain; Adjunctive treatment for post-surgical and post-trauma acute pain; Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities; Relief of pain associated with arthritis. Programs P1-P8, P10-P13.
    Indications for Use (EMS)Temporary relaxation of muscle spasms; Prevent or retard disuse atrophy; Increase of local blood flow in the treatment area; Re-educate muscles; Maintain or increase the range of motion; Prevention of venous thrombosis of the calf muscles immediately after surgery. Program P9.
    Prescription or OTC UsePrescription only. (Predicate was OTC and Prescription. This is noted as eliminating risks associated with OTC use.)
    Power SourceRechargeable (lithium-ion battery). (Predicate was rechargeable or non-rechargeable. Noted as not introducing new risks.)
    Functions and DesignElectrical stimulation only. (Predicate included electrical stimulation and heat. This is noted as eliminating risks associated with the heat function.)
    Maximum Output Voltage (Volts +/- 20%) at 500ΩRanges from 29.1V (P10) to 30.2V (multiple programs). (Compared to predicate's 30.2V to 57.6V. Noted as in range or below predicate, not raising new safety/effectiveness questions.)
    Maximum Output Voltage (Volts +/- 20%) at 2KΩ57.9V (all programs). (Compared to predicate's 57.9V to 96.0V. Noted as in range or below predicate, not raising new safety/effectiveness questions.)
    Maximum Output Voltage (Volts +/- 20%) at 10KΩN/A (Device stops delivering current at this impedance for safety). (Compared to predicate's 124V-134V. Noted as a safety feature that prevents measurements at this impedance).
    Maximum Output Current (mA +/- 20%) at 500ΩRanges from 58.2mA (P10) to 60.4mA (multiple programs). (Compared to predicate's 60.4mA to 115.2mA. Noted as in range or below predicate, not raising new safety/effectiveness questions.)
    Maximum Output Current (mA +/- 20%) at 2KΩ28.95mA (all programs). (Compared to predicate's 28.95mA to 48.0mA. Noted as in range or below predicate, not raising new safety/effectiveness questions.)
    Maximum Output Current (mA +/- 20%) at 10KΩN/A (Device stops delivering current at this impedance for safety). (Compared to predicate's 12.4mA-13.4mA. Noted as a safety feature that prevents measurements at this impedance).
    Pulse Width (µSec)Ranges from 57.5µSec (P12) to 247.5µSec (P3, P9). (Compared to predicate's 92µSec-100µSec. Noted as not raising new safety/effectiveness questions.)
    Frequency (Hz)Ranges from 2Hz (P3, P6, P8 modulated) to 100Hz (P1, P4, P5, P7, P6). (Compared to predicate's 156.2Hz-178.5Hz. Noted as in range or below predicate, not raising new safety/effectiveness questions.)
    Maximum Phase Charge (µC) at 500ΩRanges from 3.5µC (P12) to 14.9µC (P3). (Compared to predicate's 16.9µC-23.0µC. Noted as in the same range or lower than predicate, not raising new safety/effectiveness questions.)
    Maximum Current Density (mA/cm²) at 500ΩRanges from 1.7mA/cm² (P8) to 3.0mA/cm² (multiple programs). (Compared to predicate's 3.26mA/cm²-3.29mA/cm². Noted as in the same range or higher but within limits, not raising new safety/effectiveness questions, specifically
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