Cala kIQ Plus

Cala kIQ Plus is a wrist-worn electrical stimulator that delivers transcutaneous afferent patterned stimulation (TAPS) to the median and radial nerves to temporarily relieve hand tremors in adults with essential tremor or Parkinson's disease. The device consists of a stimulator, detachable band with electrodes, and a base station for charging, and is operated by patients at home.

Both the subject device and predicate use identical TAPS technology delivered through electrodes on a wearable band. Key modifications to Cala kIQ Plus include firmware updates introducing three therapy modes (A, B, C) instead of one, automatic stimulation intensity setting instead of manual, calibration at each session instead of once during setup, extended band shelf-life from 3 to 18 months, and frequency range of 50-150 Hz instead of fixed 150 Hz. All other electrical specifications, materials, and hardware remain identical.

IEC 60601-2-10 (electrical safety and EMC testing), IEC 62304 (software verification and validation), FDA guidance on device software functions (June 2023), and simulated use testing. Extended shelf-life testing was conducted to validate the 18-month wristband lifespan.

The subject device has identical intended use, target population, anatomical site, and operating principle as the predicate Cala kIQ (K243848). Modifications are limited to firmware, user interface, and labeling with no hardware changes. Comprehensive non-clinical and clinical testing demonstrated that the new therapy modes and operational changes raise no new questions of safety or effectiveness, with clinical study showing comparable tremor improvements and safety profiles across all therapy modes.