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FDA Listed | OTC | ReusableEvidence for an Off-Label Solution for DysmenhorreaA Drug-Free AlternativeHUSH TECH, LLC240 West 75th StreetNew York, NY 10023Evaluate the evidence and decide if WAVE is right for your patients in need of menstrual pain relief.Find out morewww.hush.llc | wavebyhush.comFlexStem™ adaptsto a variety of anatomies,enabling full range of motionnecessary for daily activities. Message
Efficacy BenefitsFDA Regulatory Status WAVE is an FDA regulated, OTC, Class 2 medical device. It is currently listed with the FDA under Product Code: KXQ. Since dysmenorrhea is not considered a sexual dysfunction, Hush Tech is preparing an FDA 510(k) submission that will include clinical data supporting an additional indication for the relief of dysmenorrhea.Indication of UseWAVE is a medical device for the treatment of sexual dysfunction which includes the relief of pelvic pain.Off-Label UseWAVE is a medical device for the treatment of dysmen-orrhea. It reduces menstrual pain symptoms, including cramps, abdominal pain and backache. This use has not been approved by the FDA because they have yet to evaluate our safety and efficacy data.WAVE versus TENS DevicesPublished Clinical Trials comparing WAVE’spredecessor to Ibuprofen showed it was:As Effective as Ibuprofen for Pain Relief (P<0.010).Eliminated pain or almost eliminated pain in 50% of subjects with 1 to 2 hours of treatment. Statistically significantly faster than Ibuprofen during the 1st Hour of treatment.SummaryWAVE represents the latest advancement of the VIPON device which has demonstrated efficacy in relieving dysmenorrhea in published clinical trials. Both VIPON and WAVE employ vibratory stimulus to achieve their therapeutic effects. Bench testing indicates that the vibratory performance characteris-tics of the two devices are comparable, suggesting that WAVE delivers therapeutic benefits similar to VIPON. WAVE delivers vibratory stimulus directly to the pelvic ganglia; stimulating, to the point of anesthe-tizing, the conductivity of the afferent pain fibers.Hush Tech is pleased to present scientific information about potential unapproved uses of its WAVE device to support healthcare professionals in making informed clinical decisions for patient care.Delivers low-frequency (125 Hz) vibratory stimulus. FlexStem™ ensures ease of insertion, precision placement and freedom of movement.Simple One Button Operation.Uses a single, inexpensive, LR44 battery.Ergonomic finger grip for controlled placement and removal.12345Wave’s round, smooth surface and small diameter makes it easy to insertVIPON Clinical Study ReportBench Test ReportDr. Bitzer ReportScientific ReportsSpeed Meets Relief works faster than ibuprofenWAVE Uses an Innovative Mechanism of Action.Unlike traditional TENS units that use electrode wires, WAVE is wireless, lightweight (15g), and provides users freedom of movement without limitations. WAVE sets itself apart from TENS devices by elimi-nating the need for costly consumables beyond the battery, offering greater convenience and affordability. Regarding safety, according to the FDA’s MDR data-base, between 2019 and 2023, TENS devices were associated with 26 adverse events, compared to just 2 for vibration-based devices like WAVE. Notably, these 2 events were unrelated to the device itself.LIVIA is the only TENS device that has received FDA clearance for relief of dysmenorrhea. However, its FDA 510(k) K183110 states: "LIVIA is indicated for tem-porary relief of pain associated with dysmenorrhea when used together with over-the-counter pain medication." In contrast, clinical trials of WAVE’s predecessor devices demonstrated that most users achieved satisfactory pain relief without the need for OTC pain medication.On/Off Button4Finger GripFlexStem™LR44 Battery Stainless-SteelRounded Tip 5213
Efficacy BenefitsFDA Regulatory Status WAVE is an FDA regulated, OTC, Class 2 medical device. It is currently listed with the FDA under Product Code: KXQ. Since dysmenorrhea is not considered a sexual dysfunction, Hush Tech is preparing an FDA 510(k) submission that will include clinical data supporting an additional indication for the relief of dysmenorrhea.Indication of UseWAVE is a medical device for the treatment of sexual dysfunction which includes the relief of pelvic pain.Off-Label UseWAVE is a medical device for the treatment of dysmen-orrhea. It reduces menstrual pain symptoms, including cramps, abdominal pain and backache. This use has not been approved by the FDA because they have yet to evaluate our safety and efficacy data.WAVE versus TENS DevicesPublished Clinical Trials comparing WAVE’spredecessor to Ibuprofen showed it was:As Effective as Ibuprofen for Pain Relief (P<0.010).Eliminated pain or almost eliminated pain in 50% of subjects with 1 to 2 hours of treatment. Statistically significantly faster than Ibuprofen during the 1st Hour of treatment.SummaryWAVE represents the latest advancement of the VIPON device which has demonstrated efficacy in relieving dysmenorrhea in published clinical trials. Both VIPON and WAVE employ vibratory stimulus to achieve their therapeutic effects. Bench testing indicates that the vibratory performance characteris-tics of the two devices are comparable, suggesting that WAVE delivers therapeutic benefits similar to VIPON. WAVE delivers vibratory stimulus directly to the pelvic ganglia; stimulating, to the point of anesthe-tizing, the conductivity of the afferent pain fibers.Hush Tech is pleased to present scientific information about potential unapproved uses of its WAVE device to support healthcare professionals in making informed clinical decisions for patient care.Delivers low-frequency (125 Hz) vibratory stimulus. FlexStem™ ensures ease of insertion, precision placement and freedom of movement.Simple One Button Operation.Uses a single, inexpensive, LR44 battery.Ergonomic finger grip for controlled placement and removal.12345Wave’s round, smooth surface and small diameter makes it easy to insertVIPON Clinical Study ReportBench Test ReportDr. Bitzer ReportScientific ReportsSpeed Meets Relief works faster than ibuprofenWAVE Uses an Innovative Mechanism of Action.Unlike traditional TENS units that use electrode wires, WAVE is wireless, lightweight (15g), and provides users freedom of movement without limitations. WAVE sets itself apart from TENS devices by elimi-nating the need for costly consumables beyond the battery, offering greater convenience and affordability. Regarding safety, according to the FDA’s MDR data-base, between 2019 and 2023, TENS devices were associated with 26 adverse events, compared to just 2 for vibration-based devices like WAVE. Notably, these 2 events were unrelated to the device itself.LIVIA is the only TENS device that has received FDA clearance for relief of dysmenorrhea. However, its FDA 510(k) K183110 states: "LIVIA is indicated for tem-porary relief of pain associated with dysmenorrhea when used together with over-the-counter pain medication." In contrast, clinical trials of WAVE’s predecessor devices demonstrated that most users achieved satisfactory pain relief without the need for OTC pain medication.On/Off Button4Finger GripFlexStem™LR44 Battery Stainless-SteelRounded Tip 5213
Efficacy BenefitsFDA Regulatory Status WAVE is an FDA regulated, OTC, Class 2 medical device. It is currently listed with the FDA under Product Code: KXQ. Since dysmenorrhea is not considered a sexual dysfunction, Hush Tech is preparing an FDA 510(k) submission that will include clinical data supporting an additional indication for the relief of dysmenorrhea.Indication of UseWAVE is a medical device for the treatment of sexual dysfunction which includes the relief of pelvic pain.Off-Label UseWAVE is a medical device for the treatment of dysmen-orrhea. It reduces menstrual pain symptoms, including cramps, abdominal pain and backache. This use has not been approved by the FDA because they have yet to evaluate our safety and efficacy data.WAVE versus TENS DevicesPublished Clinical Trials comparing WAVE’spredecessor to Ibuprofen showed it was:As Effective as Ibuprofen for Pain Relief (P<0.010).Eliminated pain or almost eliminated pain in 50% of subjects with 1 to 2 hours of treatment. Statistically significantly faster than Ibuprofen during the 1st Hour of treatment.SummaryWAVE represents the latest advancement of the VIPON device which has demonstrated efficacy in relieving dysmenorrhea in published clinical trials. Both VIPON and WAVE employ vibratory stimulus to achieve their therapeutic effects. Bench testing indicates that the vibratory performance characteris-tics of the two devices are comparable, suggesting that WAVE delivers therapeutic benefits similar to VIPON. WAVE delivers vibratory stimulus directly to the pelvic ganglia; stimulating, to the point of anesthe-tizing, the conductivity of the afferent pain fibers.Hush Tech is pleased to present scientific information about potential unapproved uses of its WAVE device to support healthcare professionals in making informed clinical decisions for patient care.Delivers low-frequency (125 Hz) vibratory stimulus. FlexStem™ ensures ease of insertion, precision placement and freedom of movement.Simple One Button Operation.Uses a single, inexpensive, LR44 battery.Ergonomic finger grip for controlled placement and removal.12345Wave’s round, smooth surface and small diameter makes it easy to insertVIPON Clinical Study ReportBench Test ReportDr. Bitzer ReportScientific ReportsSpeed Meets Relief works faster than ibuprofenWAVE Uses an Innovative Mechanism of Action.Unlike traditional TENS units that use electrode wires, WAVE is wireless, lightweight (15g), and provides users freedom of movement without limitations. WAVE sets itself apart from TENS devices by elimi-nating the need for costly consumables beyond the battery, offering greater convenience and affordability. Regarding safety, according to the FDA’s MDR data-base, between 2019 and 2023, TENS devices were associated with 26 adverse events, compared to just 2 for vibration-based devices like WAVE. Notably, these 2 events were unrelated to the device itself.LIVIA is the only TENS device that has received FDA clearance for relief of dysmenorrhea. However, its FDA 510(k) K183110 states: "LIVIA is indicated for tem-porary relief of pain associated with dysmenorrhea when used together with over-the-counter pain medication." In contrast, clinical trials of WAVE’s predecessor devices demonstrated that most users achieved satisfactory pain relief without the need for OTC pain medication.On/Off Button4Finger GripFlexStem™LR44 Battery Stainless-SteelRounded Tip 5213
FDA Listed | OTC | ReusableEvidence for an Off-Label Solution for DysmenhorreaA Drug-Free AlternativeHUSH TECH, LLC240 West 75th StreetNew York, NY 10023Evaluate the evidence and decide if WAVE is right for your patients in need of menstrual pain relief.Find out morewww.hush.llc | wavebyhush.comFlexStem™ adaptsto a variety of anatomies,enabling full range of motionnecessary for daily activities.
FDA Listed | OTC | ReusableEvidence for an Off-Label Solution for DysmenhorreaA Drug-Free AlternativeHUSH TECH, LLC240 West 75th StreetNew York, NY 10023Evaluate the evidence and decide if WAVE is right for your patients in need of menstrual pain relief.Find out morewww.hush.llc | wavebyhush.comFlexStem™ adaptsto a variety of anatomies,enabling full range of motionnecessary for daily activities.