FDA-Cleared Class II Device

    NS100 Neuromodulation Therapy

    by NeuroDynamics Global

    Our FDA-cleared neuromodulation therapy is designed to help reduce chronic pain associated with painful diabetic neuropathy through a 20-day temporary protocol.

    Device Specifications

    The NeuroDynamics Global system is engineered for clinical efficacy and patient comfort.

    Dimensions
    Compact lead design
    Weight
    Lightweight wearable
    Power
    External pulse generator
    Stimulation
    Programmable parameters
    Waveform
    Biphasic electrical pulses
    Duration
    20-day wear period

    Peripheral Nerve Electrical Stimulation

    NeuroDynamics Global delivers targeted electrical stimulation to peripheral nerves to help modulate pain signals associated with painful diabetic neuropathy.

    20-Day Temporary Protocol

    Unlike permanent implants, the NeuroDynamics Global device is worn for a defined 20-day period and then removed in a simple office procedure.

    FDA-Cleared Class II Device

    NeuroDynamics Global has received FDA clearance as a Class II medical device for the treatment of chronic pain due to PDN.

    Minimally Invasive Design

    Designed for implantation by trained healthcare providers, with minimal disruption to practice workflow.

    20-Day Protocol Timeline

    A temporary therapy designed for meaningful, durable relief.

    Day 0

    Device Implantation

    Minimally invasive surgical procedure under topical anesthesia. Patient receives training on device use.

    Days 1-5

    Therapy Initiation

    Patient wears device continuously. Stimulation parameters adjusted as needed.

    Days 6-15

    Active Treatment

    Ongoing therapy delivery. Patient continues normal daily activities.

    Days 16-19

    Therapy Completion

    Final days of stimulation protocol. Follow-up assessment scheduled.

    Day 20

    Device Removal

    Simple in-office removal procedure. Patient outcomes evaluated.

    Treatment Progress

    Day 0
    Implant
    Day 5
    Initiation
    Day 10
    Mid-point
    Day 15
    Active
    Day 20
    Removal

    Clinical Workflow

    A streamlined process designed for real-world clinical settings.

    1

    Patient Identification

    Identify PDN patients who may benefit from NeuroDynamics Global therapy

    2

    Coverage Verification

    Verify insurance coverage and obtain prior authorization

    3

    Procedure Scheduling

    Schedule implantation procedure and patient training

    4

    Device Implantation

    Perform implantation under topical anesthesia

    5

    20-Day Therapy

    Patient wears device; clinical support as needed

    6

    Device Removal

    Remove device and document patient outcomes

    Full operational support at every step

    NeuroDynamics Global provides training, clinical liaison support, and revenue cycle management assistance to help ensure smooth implementation.

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    A neuromodulation pathway that targets pain and glucose regulation

    NS100 is designed to engage multiple biologic pathways involved in glucose regulation while simultaneously treating painful diabetic neuropathy. Individual results vary.

    Increases insulin secretion

    Targeted neuromodulation is associated with enhanced endogenous insulin release in observational study data.

    Reduces hepatic glucose production

    Engagement of autonomic pathways is associated with downregulation of hepatic glucose output.

    Improves insulin sensitivity

    Combined autonomic and peripheral effects are associated with improved cellular response to insulin.

    Mechanistic descriptions reflect observed pathways in published and ongoing NS100 research; not a claim of cure or disease modification. See clinical research abstracts for study details.

    Indications for Use

    The NeuroDynamics Global device is indicated for the treatment of chronic pain associated with painful diabetic neuropathy (PDN). The device should be used under the direction of a licensed healthcare provider trained in its use.

    Important Safety Information

    The NeuroDynamics Global device is an FDA-cleared Class II medical device. As with any medical procedure, there are potential risks. Patients should discuss all risks and benefits with their healthcare provider. Full prescribing information is available upon request.

    Ready to bring NeuroDynamics Global to your practice?

    Contact us for detailed clinical information, training requirements, and program implementation support.