I-FDA 510(k) Imvume Inikezwe I-Joytech I-Large Arm Digital Blood Pressure Monitors

I-Joytech imemezela ngokuziqhenya ukuthi iziqaphi zethu zohlobo lwengalo ze-DBP-6186 kanye ne-6286B ezizenzakalelayo ngokugcwele zithole imvume ye-FDA 510(k), manje esekela izilinganiso zengalo ezinkulu ukusuka ku-40cm ukuya ku-56cm. Idizayinelwe abantu abadala kanye nentsha engaphezu kweminyaka engu-12 ubudala, laba baqaphi bakala ngokunembile umfutho we-systolic ne-diastolic nezinga lokushaya kwenhliziyo.

Ifakwe izibonisi ezinkulu ze-LCD ukuze zifundeke kalula, amadivayisi angaphinda alungiselelwe ngoxhumano lwe-Bluetooth, okuvumela ukulandelela impilo okulula ngezinhlelo zokusebenza zeselula. Inketho entsha enkulu ye-cuff inweba ukusebenziseka kubasebenzisi abanosayizi bezingalo abakhulu, iqinisekisa izilinganiso ezinembile ngaphandle kokuphatheka kabi.

Lokhu kugunyazwa kwe-FDA kuqinisekisa izindinganiso eziphakeme nokuphepha kwamadivayisi ethu, kunikeza abahlinzeki bezempilo nabasebenzisi basekhaya ukuguquguquka okwengeziwe nokuzethemba ekulawuleni umfutho wegazi ophakeme. I-Joytech isalokhu izibophezele ekuletheni izixazululo ezintsha, ezinokwethenjelwa zezidingo zezempilo zomhlaba wonke.

Ngemibuzo noma imininingwane eyengeziwe, sicela ungangabazi finyelela kithi.