NeuroTrigger

NeuroTrigger Basic is a companion control application designed for use with the NeuroTrigger Basic System (Model NT11), cleared for use by the FDA (K223027) and AMAR (37530001) — a neuromuscular electrical stimulation (NMES) medical device that includes a stimulator and disposable single-use electrodes.

The NeuroTrigger Basic System delivers controlled electrical stimulation through specially designed electrodes and is intended to support:

• Prevention or retardation of disuse muscle atrophy.
• Muscle re-education.
• Maintenance or improvement of the range of motion.

The application enables users, under professional guidance, to operate and manage therapy sessions as part of a prescribed treatment plan.

The NeuroTrigger Basic system and this application are intended for use only under prescription (Rx Only). Use of the NeuroTrigger Basic System and this application must be initiated and supervised by a licensed healthcare professional.

The system is available by prescription only and should be used strictly in accordance with the Instructions for Use provided with the device.

This application is intended to be used only in conjunction with approved NeuroTrigger Basic medical hardware and does not replace professional medical advice, diagnosis, or treatment.

Users should always consult a qualified healthcare provider before first use and before making any medical decisions.

Regulatory and Jurisdiction Information

The NeuroTrigger Basic medical hardware has obtained regulatory clearance only in the following jurisdictions:

• United States of America.
• Israel.

This application is intended exclusively for use with NeuroTrigger Basic hardware that has been legally marketed and cleared for use in these jurisdictions.

Use of the NeuroTrigger Basic System and this application outside the jurisdictions listed above has not received regulatory clearance and is not authorized.

Important Information

Please read and follow all Instructions for Use and safety information provided with the NeuroTrigger Basic System before using the device and this application.