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FDA 510(k) & PMA Approved Devices — 22 products

Total Devices22
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K213197 MyOnyx SystemIPF2022-06-17 View
510(k) K201014 MyOnyx SystemKPI2021-01-13 View
510(k) K053434 MYOTRAC INFINITI ELECTRICAL STIMULATORKPI2006-03-15 View
510(k) K053266 MYOTRAC INFINITIIPF2005-12-29 View
510(k) K925681 MYOTRAC2D/CSHIR1995-09-29 View
510(k) K932149 THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODEHIR1995-05-11 View
510(k) K935213 INCONTROLHIR1995-05-11 View
510(k) K915858 MYOTRAC2HCC1992-09-09 View
510(k) K915859 MYOTRAC/S, MYODAC/SHCC1992-09-09 View
510(k) K913898 MYOTRAC+/S, MYODAC+/SHCC1992-03-26 View
510(k) K903497 FLEXCOMP DSP & PROCOMPHCC1991-02-12 View
510(k) K896409 M(3):MICRO MUSCLE MONITORHCC1990-10-09 View
510(k) K894840 MYODAC2 BIOFEEDBACK DEVICEHCC1989-10-13 View
510(k) K883597 MYODACHCC1988-11-16 View
510(k) K881416 MYOTRACHCC1988-09-26 View
510(k) K850643 HR/BVP 100T HEART RATE MONITORHCC1985-05-17 View
510(k) K850642 TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBAHCC1985-05-17 View
510(k) K834519 CALMTONEHCC1984-01-30 View
510(k) K831955 HR 100TJOM1983-08-11 View
510(k) K823146 CALMSET 3 TMHCC1982-12-03 View
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