Puas yog Class 1 cov cuab yeej siv kho mob uas yuav siv rau lub hom phiaj kho mob tab sis yuav tsum tsis txhob siv rau hauv kev phais lossis qhov xwm txheej pheej hmoo siab, lossis hauv qhov xwm txheej muaj kev pheej hmoo loj nrog kev sib cuag nrog cov kua lossis cov khoom sib kis.
Cov no yog Class 1 cov cuab yeej siv kho mob thiab tsis raug rau FDA 501 (k) qhov yuav tsum tau tshaj tawm. Cov khoom no yog tsim los ntawm FDA-sau npe tsim khoom
Cov qhov ncauj qhov ntswg pov tseg
3-txheej tsis-woven npuag nrog pom zoo thiab pom kev ua pa zoo
Yooj yim rau hnav rau lub sijhawm ntev thaum tiv thaiv kev tiv thaiv ntau tshaj plaws