Cala kIQ

Cala kIQ is a wrist-worn electrical stimulator device that delivers transcutaneous afferent patterned stimulation (TAPS) to treat hand tremors in adults with essential tremor or Parkinson's disease. The device detects tremor frequency using motion sensors and applies a customized stimulation pattern to the median and radial nerves after calibration by a physician.

The subject device is identical to the predicate device in all respects except for the formulation of the proprietary electrode material and the Band shelf-life (reduced from 18 months to 3 months pending additional stability testing). Both devices use biphasic rectangular waveforms at 150 Hz, 4V/500Ω maximum output, 6 electrodes of 1.32 cm² each, and rechargeable lithium-ion batteries with AC-powered chargers.

ISO-10993 biocompatibility testing was performed on patient-contacting materials. The device conforms to IEC 60601 electrical safety standards and EMC (electromagnetic compatibility) requirements.

The new electrode material formulation is the only design change, and all patient-contacting materials including the new electrode material were tested and demonstrated biocompatible per ISO-10993. Since the subject device retains identical technological characteristics, indications for use, operating principles, and energy delivery parameters as the predicate, and no new clinical or non-clinical safety concerns arise from the electrode material change, the performance data from previous submissions remain applicable and support that the subject device meets the same special controls as the predicate.