Encora X1

The Encora X1™ is a wearable stimulator worn on the wrist that delivers mechanical stimulation (continuous or pulsed modes) to treat hand tremors in adults with essential tremor. It includes a rechargeable stimulator with motion sensors, a wristband with four embedded linear resonant actuators, and a charging station. The device is indicated to aid in the relief of hand tremors in the treated limb during stimulation.

The Encora X1 uses four linear resonant actuators embedded in the wristband, compared to the predicate's three electrodes. It employs a 3.7V lithium-polymer rechargeable battery versus the predicate's lithium-ion battery. Both devices share a detachable stimulator with on-board motion sensors (gyroscope and triaxial accelerometer), AC-powered charging stations, and embedded firmware control. The devices are comparable in weight (58g total) and dimensions.

ISO 10993-1:2018 (biocompatibility), IEC60601-1 and collateral/particular standards (EMC and electrical safety), internal standard test methods for stimulation waveform conformance, and FDA guidance for software verification and validation (V&V) testing including hazard analysis.

Encora X1 and Cala ONE are substantially equivalent external upper limb tremor stimulators with the same intended use and design principle. Clinical evidence from the ULTRE double-blind sham-controlled study (N=43) and 90-Day Home Use Study (N=59) demonstrates similar safety and effectiveness profiles. Both devices showed tremor relief with well-tolerated non-serious adverse events. Technological differences (linear resonant actuators vs. electrodes, battery chemistry) do not impact safety and effectiveness, as demonstrated through performance and non-clinical testing.