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The Synchrony (20-3000) is an electrical stimulation device indicated for the following uses: **Functional Electrical Stimulation (FES).** - Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury. **NeuroMuscular Electrical Stimulation (NMES).** - Maintenance and/or increase of hand range of motion. - Prevention and/or retardation of disuse atrophy. - Increase in local blood circulation. - Reduction of muscle spasm. - Re-education of muscles.

The Synchrony (20-3000) system is a functional electrical stimulation (FES) device and a powered muscle stimulator. It is specifically designed to enhance hand functionality in patients with arm paresis through a range of customizable therapies. The system integrates five major components: the Stimulator, Sensor, Patient Interface (electrodes), Motor Point Probe, and Clinician App. The therapies are directed and programmed by a clinician through an iOS based application and then the patient may apply the therapy at their home with the Stimulator and Sensor. The Synchrony system supports three primary therapeutic modes: Contralaterally Controlled Electrical Stimulation (CCFES), cyclical Neuromuscular Electrical Stimulation (CNMES), and Functional Task Practice (FTP). The CCFES mode uses sensor data from the patient's unimpaired side to control the timing, intensity, and movement of the paretic hand/arm, synchronizing stimulation with natural motor patterns. The cyclical NMES mode delivers repetitive stimulation to targeted muscles, aiding in muscle re-training, as described in the systematic review of research studies using cyclic NMES. The FTP mode allows for direct control of hand movements during task-oriented exercises, using real-time sensor feedback and stimulator output. Stimulation is delivered through up to four electrodes placed on identified motor points, using symmetric balanced biphasic pulses. The system offers preset stimulation amplitudes of 20mA, 40mA, and 60mA, with a pulse width adjustable between 1-250 µsec, providing high precision with 1 µsec resolution. The device's enclosure is constructed from biocompatible ABS Cycoloy, ensuring durability and patient safety, and is rated IP22 for ingress protection. The stimulator can operate independently or in conjunction with the Synchrony Sensor, depending on the therapy mode selected. The Sensor, which communicates wirelessly with the Stimulator via Bluetooth Low Energy (BLE), uses a Class I laser that is compliant with 21 CFR 1040.10 and 21 CFR 1040.11 to measure hand opening and closure distances, enabling accurate therapeutic adjustments. Both the Stimulator and Sensor are wirelessly charged using an FCC Part 15 compliant charging pad, enhancing ease of use and handling. The Synchrony system is engineered for ease of use with user-friendly control interfaces for both patients and clinicians. It incorporates a range of safety mechanisms to ensure effective and safe operation, making it a versatile and reliable tool for improving hand functionality through personalized therapeutic interventions.