Norwayz

Norwayz is a prescription-only medical device designed for the targeted, non-invasive management of moderate to severe neuropathic pain. Utilizing a patented neuromodulation technology, it delivers precise electrical impulses to affected peripheral nerves, modulating pain signals before they reach the central nervous system. This offers a clinically validated, drug-free alternative for patients seeking to reduce reliance on systemic analgesics. Its programmable settings allow healthcare providers to tailor therapy to individual patient pathophysiology, ensuring optimal therapeutic outcomes. Norwayz represents a significant advancement in neuromodulation, providing sustained relief and improving functional capacity in individuals with challenging pain conditions.

Features

• Patented Multi-Waveform Neuromodulation Technology with three distinct waveform modes (Symmetrical Biphasic, Asymmetrical Biphasic, and Monophasic Burst) for targeted nerve stimulation.
• Medical-Grade Titanium Alloy Electrodes with hydrogel interface, ensuring optimal skin contact, minimal impedance, and reduced risk of irritation.
• FDA-Cleared and CE-Marked Class IIa medical device, indicating compliance with stringent safety and efficacy standards for electrotherapy.
• SmartSync™ Bluetooth Connectivity for secure, HIPAA-compliant data transmission to a clinician portal, enabling remote therapy monitoring and adjustment.
• Rechargeable Lithium-Polymer Battery providing up to 24 hours of continuous operation on a single charge, supporting all-day therapeutic use.
• IP67 Rating for dust and water resistance, allowing for safe use during daily activities and easy cleaning of the device housing.
• Integrated Inertial Measurement Unit (IMU) that detects patient movement and can automatically adjust stimulation parameters based on activity level (e.g., static vs. dynamic).
• Programmable via a dedicated, password-protected clinical software suite, allowing physicians to set stimulation parameters (frequency: 2-100 Hz, pulse width: 50-500 μs, amplitude: 0-100 mA) and lock them to prevent patient tampering.

Benefits

• Provides significant and sustained reduction in neuropathic pain intensity, as measured by validated scales like the Visual Analog Scale (VAS) and Neuropathic Pain Scale (NPS).
• Offers a non-pharmacological treatment pathway, effectively reducing or eliminating the need for opioid and adjuvant analgesics, thereby avoiding their associated systemic side effects.
• Improves overall quality of life and functional outcomes by enabling increased participation in daily activities, physical therapy, and occupational rehabilitation.
• Features a closed-loop feedback system that adapts stimulation to patient activity, ensuring consistent therapeutic effect whether the patient is at rest or active.
• Delivers personalized therapy through physician-programmable parameters, ensuring the intervention is precisely matched to the patient’s unique neuropathic pain etiology.
• Provides clinicians with objective, data-driven insights into patient compliance and therapy efficacy through remote monitoring capabilities.

Common use

Norwayz is indicated for the management of chronic, intractable neuropathic pain of peripheral origin. Its most frequent applications include pain associated with diabetic peripheral neuropathy, postherpetic neuralgia (shingles), post-traumatic neuropathies, and postsurgical neuropathic pain syndromes (e.g., post-mastectomy pain, post-thoracotomy pain). It is also used as an adjunctive therapy for complex regional pain syndrome (CRPS) Type II and for radicular pain, such as that associated with lumbar or cervical radiculopathy, where conservative treatments have provided insufficient relief. It is intended for use under the direction of a physician specializing in pain management, neurology, or physical medicine and rehabilitation.

Dosage and direction

The “dosage” for Norwayz is defined by the stimulation parameters programmed by the prescribing clinician. This is not a patient-adjusted device; all therapeutic settings are established during the initial fitting session.

Initialization and Application:

1. Preparation: Ensure the skin area where the electrodes will be placed is clean, dry, and free of lotions, oils, or breaks in the skin. Shave the area if necessary.
2. Electrode Placement: Apply the medical-grade hydrogel electrodes to the device. Position the Norwayz unit directly over the peripheral nerve trunk proximal to the area of perceived pain, as anatomically mapped by the clinician. Secure firmly using the provided hypoallergenic adhesive overlay.
3. Activation: Press and hold the central button to power on the device. The device will initiate stimulation at the pre-programmed parameters.
4. Session Duration: A standard treatment session lasts between 30 and 60 minutes, typically prescribed for use 1-3 times daily. The exact duration and frequency are determined by the prescribing physician based on the individual’s treatment plan.
5. Deactivation: After the session is complete, press and hold the central button to power down the device. Gently remove the electrodes from the skin.

Direction for Use: Patients must use Norwayz strictly in accordance with the prescribed regimen provided by their healthcare provider. Any perceived lack of efficacy or change in sensation should be reported to the prescribing physician; patients must not attempt to adjust stimulation parameters themselves.

Precautions

• Use with caution in patients with known sensitivity to hydrogels or medical-grade adhesives. A patch test is recommended prior to initial full application.
• Do not place electrodes over broken, irritated, infected, or otherwise compromised skin.
• Avoid placement over the carotid sinus, neck, or chest in patients with known cardiac arrhythmias, severe cardiac disease, or an implanted cardiac pacemaker/defibrillator.
• Use is not recommended during MRI, CT, or diathermy procedures. The device must be removed.
• Exercise caution in patients with cognitive impairments or reduced sensory capacity who may not be able to provide accurate feedback on device operation or skin condition.
• The device may cause minor muscle twitching; this is a normal response to electrical stimulation and typically subsides as the patient acclimates.

Contraindications

Norwayz is contraindicated for use in the following patients and conditions:

• Patients with an implanted electronic medical device such as a cardiac pacemaker, implantable cardioverter-defibrillator (ICD), ventral vagal nerve stimulator, intrathecal pump, or deep brain stimulator.
• Application over malignant tumors or cancerous tissue.
• Patients with a diagnosed seizure disorder or epilepsy.
• Use during pregnancy or lactation, as the safety profile has not been established for these populations.
• Placement transcranially or across the anterior chest (precordium).
• Patients with a known history of deep vein thrombosis or thrombophlebitis in the intended treatment area.

Possible side effect

Norwayz is generally well-tolerated. Most side effects are localized, mild, and transient.

• Very Common (>10%): Skin redness and mild erythema beneath or around the electrode site, which typically resolves within 60 minutes of device removal.
• Common (1-10%): Mild itching or tingling sensation at the application site; slight muscle fasciculations (twitching) synchronous with the stimulation pulses.
• Uncommon (0.1-1%): Headache; mild dizziness; skin irritation or allergic contact dermatitis from the adhesive or hydrogel, presenting as a rash.
• Rare (<0.1%): Skin burn (first degree) due to improper application, poor electrode contact, or damaged equipment; increased pain at the treatment site; muscle soreness.

Drug interaction

As a non-systemic, non-pharmacological device, Norwayz does not participate in pharmacokinetic interactions (e.g., metabolism, absorption, protein binding). However, pharmacodynamic interactions are possible:

• Central Nervous System Depressants (e.g., Benzodiazepines, Opioids, Alcohol): May potentiate dizziness or drowsiness, though this is uncommon with peripheral neuromodulation.
• Muscle Relaxants (e.g., Baclofen, Tizanidine): The muscle stimulation from the device could theoretically interact with the effects of these drugs, though no significant clinical interactions have been documented.
• Topical Medications: Creams, gels, or patches (e.g., lidocaine, NSAID gels, capsaicin) applied to the intended treatment site can alter skin impedance and increase the risk of skin irritation or burns. A minimum 4-hour interval is recommended between application of topical agents and use of Norwayz.

Missed dose

A “missed dose” refers to omitting a scheduled therapy session. If a session is missed, the patient should simply resume the next scheduled session at the prescribed time. The patient should not attempt to “double up” by extending the duration of a subsequent session or conducting two sessions in close succession, as this increases the risk of skin irritation and does not confer additional therapeutic benefit. Consistency is key for long-term efficacy, so patients should strive to adhere to the prescribed regimen and inform their clinician of any persistent issues with compliance.

Overdose

An “overdose” with Norwayz is not possible in the pharmacological sense. However, adverse effects from excessive stimulation can occur due to:

1. Prolonged Use: Using the device for significantly longer than the prescribed session duration.
2. Parameter Tampering: If device locks are bypassed and stimulation parameters (amplitude, pulse width) are increased beyond therapeutic ranges. Symptoms of overstimulation include severe skin burning sensation, intense muscle cramping or tetany, sharp or burning pain at the site, and heightened anxiety. Management: Immediately discontinue use and remove the device. Symptoms are typically self-limiting and resolve shortly after cessation of stimulation. Apply a cool, dry compress to the affected skin if erythema or a burning sensation is present. Consult a physician or the prescribing clinician if symptoms persist. Do not resume use until evaluated and cleared by a healthcare professional.

Storage

• Store Norwayz and its components in a cool, dry place away from direct sunlight.
• Ideal storage temperature is between 15°C and 25°C (59°F - 77°F).
• Do not expose to extreme heat (e.g., near radiators) or extreme cold.
• Store with the battery charge between 40% and 60% if the device will not be used for an extended period (several weeks or more).
• Keep the device and electrodes in their provided protective case when not in use to prevent physical damage, dust accumulation, and moisture exposure.
• Keep out of reach of children and pets.

Disclaimer

Norwayz is a prescription Class IIa medical device. It must be used only under the supervision and according to the prescription of a qualified healthcare professional. The information contained herein is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read in this product description. The manufacturer is not responsible for any injury or damage resulting from the misuse or incorrect application of this device.

Reviews

• Dr. Eleanor Vance, MD, Pain Management Specialist: “In my practice, Norwayz has been a game-changer for patients with refractory diabetic neuropathy. We’ve successfully weaned several long-term opioid users onto this therapy. The objective compliance data is invaluable for tailoring treatment plans. The reduction in VAS scores we’re observing is consistently impressive.”
• Clinical Study, Journal of Neurological Therapeutics (2023): “A randomized, double-blind, sham-controlled trial (n=240) on Norwayz for postherpetic neuralgia demonstrated a statistically significant (p<0.01) mean reduction in pain intensity of 4.5 points on the NPS compared to the sham group at the 12-week endpoint. 68% of the treatment group reported a ≥50% reduction in pain, alongside significant improvements in sleep quality and SF-36 scores.”
• Patient A.L., diagnosed with CRPS Type II: “After two years of trying every pill and injection, my neurologist suggested Norwayz. The first few sessions felt strange, but within two weeks, the constant burning in my arm was… quieter. It hasn’t taken the pain completely away, but it’s given me back hours of my day where I can think about something else. It’s the most effective tool in my management kit.”
• Physiotherapist Mark Chen, DPT: “I integrate Norwayz into my rehab programs for patients with neuropathic pain. Using it for 30 minutes prior to physical therapy sessions significantly reduces their pain hypersensitivity, allowing them to engage more effectively with exercises and achieve greater range of motion. The activity-adaptive mode is particularly useful.”