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Bioelectronic Medicine

Taiwan
Introduction
TRWR’s bioelectronic medicine is a non-invasive electrical impulse-delivering device connected to an electrode pad set by conductive wire. It delivers mild electrical impulses in specific proprietary frequency combinations to the human body for different chronic diseases complementary treatments.
Features / strengths
◎Product: A portable, non-invasive microcurrent electrical nerve stimulator that delivers mild electrical stimulation through the skin.
◎Product function: The human body is stimulated with mild electrical impulses in specific proprietary frequency combinations depending on different indications to modulate physiological regulations that can complementary treat different chronic diseases.
◎Treatment time: According to different indications, the treatment time ranges from 40 mins – 2.5 hrs.
◎Product quality system: This product is produced by QMS certified manufacturer and is compliant with ISO 13485 Medical Device Quality Management System standard.

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Product pipeline
◎Type 2 Diabetes: Currently undergoing regulatory market approval review by Taiwan FDA as a new medical device with no predicate in the world with indication of glycemic variability reduction.
◎Type 1 Diabetes: Completed pre-clinical validation on disease onset delay with mechanism of therapeutic action studies in progress.
◎Pain: Obtained class II medical device market approval from Taiwan FDA as “Dragon Waves Resonant Home Care” Electronic Nerve Stimulator.
◎Sleep Disorder: Completed pilot clinical trials for sleep quality improvement and obstructive sleep apnea treatment.
Specification in detail
Weight
330g
Dimension
11.5(L) x 11.5(W) x 3.0(H) cm
Place of Production
Taiwan
Quality Management System
GMP-QMS & ISO13485:2016
Market Approval
Taiwan FDA submission under review, FDA & CE submissions in preparation

Information
Introduction
TRWR’s bioelectronic medicine is a non-invasive electrical impulse-delivering device connected to an electrode pad set by conductive wire. It delivers mild electrical impulses in specific proprietary frequency combinations to the human body for different chronic diseases complementary treatments.
Features / strengths
◎Product: A portable, non-invasive microcurrent electrical nerve stimulator that delivers mild electrical stimulation through the skin.
◎Product function: The human body is stimulated with mild electrical impulses in specific proprietary frequency combinations depending on different indications to modulate physiological regulations that can complementary treat different chronic diseases.
◎Treatment time: According to different indications, the treatment time ranges from 40 mins – 2.5 hrs.
◎Product quality system: This product is produced by QMS certified manufacturer and is compliant with ISO 13485 Medical Device Quality Management System standard.

--------------------------------------------------------------------------------------------------------------------------
Product pipeline
◎Type 2 Diabetes: Currently undergoing regulatory market approval review by Taiwan FDA as a new medical device with no predicate in the world with indication of glycemic variability reduction.
◎Type 1 Diabetes: Completed pre-clinical validation on disease onset delay with mechanism of therapeutic action studies in progress.
◎Pain: Obtained class II medical device market approval from Taiwan FDA as “Dragon Waves Resonant Home Care” Electronic Nerve Stimulator.
◎Sleep Disorder: Completed pilot clinical trials for sleep quality improvement and obstructive sleep apnea treatment.
Specification in detail
Weight
330g
Dimension
11.5(L) x 11.5(W) x 3.0(H) cm
Place of Production
Taiwan
Quality Management System
GMP-QMS & ISO13485:2016
Market Approval
Taiwan FDA submission under review, FDA & CE submissions in preparation

Bioelectronic Medicine

Taiwan
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