The SudoPath system is a programmable electro medical device namely a USB plug and play hardware including and electronic box, cables and reusable electrodes and associated software for help in assessment of sweat gland function using galvanic skin response measurements.
The SudoPath measurement process (pending patent) is an improved sympathetic skin response method following a constant electrical stimulation, and provides a quantitative evaluation of the sweat response according to the redox (reduction/oxidation) measurements on the bulk of the electrodes.
The sweat response is evaluated at the sole of the feet which have the highest density of eccrine sweat glands and C-fibers that travel the furthest from the brain and the spinal cord.
Through the protocol communication, the software manages the time and sequence of the electrical stimulation of the active receiving electrode and measures the conductance,voltage and latency of the contraleteral passive responding electrode.
The data are stored in the backup system of the software, and the history of the data can be displayed for the same patient with different dates.
The sudoPath is marketed only in combination with the TM-Oxi and results are managed by ANS1 Software.
Intended use and indications for use
SudoPath is a medical device for the measurement of galvanic skin response.
The SudoPath device provides values. It is the physician's responsibility to make proper judgments based on these numbers.
The device is indicated for use with the general adult population.
Prescription Use Caution: Federal law restricts this device to sale by or on the order of a physician
FDA Clearance 510K number k131568