STOPWET iontophoresis apparatus (SW01)

STOPWET is a tap water iontophoresis apparatus designed to treat hyperhidrosis (excessive sweating) of the hands and feet. Users place their hands or feet in containers with dampened absorbent pads and adjust electrical current to a comfortable level. The device includes a pulse current generator and can operate in single-limb or dual-limb treatment modes, for use in clinical or home settings by patients aged 13 and above.

STOPWET differs from the predicate Dermadry in several ways: it uses a rotary knob and light indicator interface instead of digital buttons; electrodes are integrated into containers rather than separate; it is battery-powered instead of AC-powered; maximum current output is 15 mA (versus Dermadry's 25 mA for feet); and it does not treat underarms. Both use 10 kHz monophasic square pulse waveforms with 90% duty cycle and automatic polarity reversal every 5 minutes.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-11 (home healthcare environment safety), IEC 62366-1 (usability engineering), IEC 62304 (software life cycle), ISO 10993-1 (biocompatibility), and IEC 62133 (battery safety for lithium systems).

Although STOPWET has design differences (battery power, integrated electrodes, lower current limits, smaller electrode pads), the submission argues substantial equivalence because: (1) intended use and indications are comparable for hands and feet; (2) underlying technology (tap water iontophoresis, pulse current, monophasic waveform, polarity reversal) is identical; (3) maximum power delivered to users is lower and safer (891J versus 1485J); (4) power density of 0.0066 W/cm² complies with muscle stimulator guidance limits; and (5) all critical performance parameters and safety standards are met.