Okulaba: 0 Omuwandiisi: Omuwandiisi w'omukutu Obudde bw'okufulumya: 2026-05-05 Ensibuko: Ekibanja
Tuli basanyufu okulangirira nti ebika ebipya eby’okulondoola puleesa mu layini y’ebintu ebiriwo kati ebya Joytech Healthcare bifunye obuwanguzi mu FDA 510(k) clearance , okuwagira obwetegefu bwabwe eri akatale k’ebyuma eby’obujjanjabi mu Amerika.
Olukusa lukakasa nti ebyuma bino bituukana n’ebisaanyizo by’amateeka ga Amerika ku by’okwerinda n’okukola emirimu nga ebyuma eby’obujjanjabi ebya Class II , era byenkana nnyo n’ebyuma ebimanyiddwa mu mateeka ebitundibwa.
Ebika ebipya ebirongooseddwa bye bikozesebwa mu kulondoola puleesa mu ngeri ey’otoma ku mukono ogwa waggulu nga bikoleddwa eri abantu abakulu bonna abakozesa mu maka n’embeera z’obujjanjabi.
Ebikozesebwa bino kitundu ku Joytech Healthcare’s established blood pressure monitor product line , era nga bireeta ensengeka erongooseddwa ne tekinologiya w’okupima okuwagira okulongoosa mu bumanyirivu bw’abakozesa n’okwesigamizibwa mu kupima.
They utilize an inflation-based blood pressure measurement technology , okusobozesa okupima mu kiseera ky’okufuuwa puleesa. Kino kiyamba okulongoosa obulungi bw’okupima n’obuweerero bw’omukozesa , ate nga kikuuma okusoma okutebenkedde era okwesigika.
Okusinziira ku nsengeka, ebyuma biyinza okubeeramu emirimu gino wammanga:
Cuff Tightness Indicator , okuwagira okusiiga obulungi cuff nga tonnapima
Excessive Movement Indicator , okuyamba okulongoosa okutebenkera kw’okupima nga bazuula entambula nga bakozesa
AFIB (Atrial Fibrillation) detection function , okuwagira okukebera okukuba kw’omutima okutali kwa bulijjo mu kiseera ky’okupima
MVM function , okuwa otomatiki average y'okusoma okungi okusobola okulongoosa mu kukwatagana
Emirimu gino gikoleddwa okuwagira okulondoola puleesa okwesigika mu mbeera zombi ez‟ebyobulamu awaka n‟okwekenneenya obujjanjabi.
Ensengeka za sayizi z’enkoba eziwera ziriwo, omuli sentimita 22–36, sentimita 22–42, ne sentimita 32–48 , ezikoleddwa okusobola okusikiriza okwetooloola kw’emikono gy’abantu abakulu ez’enjawulo n’okukakasa okupima okutuufu mu bibinja by’abakozesa eby’enjawulo.
FDA 510(k) yalongoosa ebika ebipya mu layini y’okulondoola puleesa eriwo
Enkola y’okulondoola puleesa ey’omukono ogwa waggulu mu ngeri ey’otoma
Tekinologiya w’okupima okusinziira ku bbeeyi y’ebintu okusobola okulongoosa obuweerero n’okukola obulungi
Optional Cuff Tightness Indicator okusobola okuteeka obulungi cuff
Optional Excessive Movement Indicator okuzuula entambula nga opima
Omulimu gw’okuzuula AFIB olw’obuyambi bw’okukebera okukuba kw’omutima okutali kwa bulijjo
Omulimu gwa MVM okulongoosa okukwatagana kw’okupima n’okuddiŋŋana
Ensengeka za sayizi ya cuff eziwera eri abakozesa abakulu
Esaanira okukozesebwa awaka n‟embeera z‟okwekenneenya obujjanjabi
Olukusa lwa FDA 510(k) lulaga nti Joytech Healthcare yeewaddeyo okugoberera amateeka n’omutindo gw’ebintu eri obutale bw’ebyobulamu mu nsi yonna, omuli ne Amerika.
Ennamba 510(k) ezikwatagana zisangibwa mu lujjudde era zikakasibwa mu FDA database , okukakasa obwerufu era okulondoolebwa.
Ebika bino ebipya ebirongooseddwa bifunibwa okwekenneenya abagaba ebyuma by’obujjanjabi, abayingiza ebintu mu ggwanga, n’emikwano gya OEM/ODM nga banoonya eby’okugonjoola okulondoola puleesa ebikwatagana n’obutale bwabwe.
Tusanyukidde enkolagana n’emikwano egyagala okwekenneenya ebintu, okukulaakulanya ebiwandiiko by’obwannannyini, n’okuwagira okuteekebwa mu katale okusaasaanya mu nsi yonna.
Joytech Ebyobulamu ye mukugu mu kukola ebyuma ebilondoola ebyobulamu by’awaka n’eby’obujjanjabi, ng’ekuguse mu byuma ebipima puleesa, ebipima ebbugumu, ebipima pulse oximeters, nebulizers, ppampu z’amabeere n’ebintu ebirala eby’ebyobulamu.
Tuwa OEM / ODM ebyuma eby'obujjanjabi solutions ebika by’ebyobulamu mu nsi yonna, abagaba, n’emikwano, nga essira tulitadde ku kugoberera amateeka, okwesigamizibwa kw’ebintu, n’okukolagana okw’ekiseera ekiwanvu.
Ku sampuli z’okwekenneenya ebintu, ebiwandiiko eby’ekikugu, oba enkolagana ebikwata ku byaffe FDA 510(k) cleared blood pressure monitor models, tuukirira ttiimu yaffe.