Ultrasound Stimulator

The Ultrasound Stimulator is a portable, rechargeable prescription device that applies ultrasonic energy to generate deep heat within body tissues. It is used in home or clinical settings to treat pain, muscle spasms, joint contractures, and related conditions, operated for up to 30 minutes per cycle (maximum 4 cycles) by or under direction of a medical professional.

The device operates at 1.5 MHz ± 10% frequency with a maximum output power of 0.60 W ± 20% and temporal average power of 0.60 W ± 20%. It features piezoelectric ultrasound generation in continuous wave mode (100% duty cycle), supports 1 or 2 applicators with 3.9 cm² effective radiating area, includes software/firmware microprocessor control, automatic shut-off and no-load trip functions, and complies with IEC 60601-2-5 for thermal safety with a maximum patient contact surface temperature of 43°C.

Compliance verified with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-5, ISO 10993-5, ISO 10993-10, IEC 60601-1-6, and IEC 60601-1-11. Testing included power output evaluation, electrical safety and EMC evaluation, thermal safety evaluation, biocompatibility evaluation, and software verification per FDA guidance for medical device software.

The subject device is identical or similar to predicate devices (ManaSport+ and sam 2.0) across all critical parameters: same 1.5 MHz frequency, identical 0.60 W output power and continuous wave mode, same indications for use treating pain and muscle spasms, identical prescription classification, equivalent cooling/temperature management despite a 30-minute cycle limit (versus 20 or 240 minutes in predicates), and compliance with the same voluntary standards including IEC 60601-2-5. The shorter treatment time and associated lower temperature rise do not create new safety or effectiveness issues, supported by thermal testing demonstrating no adverse impact.