Ekhaya » Iindaba » Iimveliso Iindaba » I-FDA 510(k) iCwangciso iNikelwe kwi-Joytech Izixhobo ezinkulu zeDijithali zoxinzelelo lwegazi

I-FDA 510(k) UCwangciso lunikelwe kwiJoytech Izixhobo ezinkulu zeDijithali zeDijithali zoxinzelelo lwegazi

Iimboniselo: 0 uMbhali: Ixesha lokupapasha loMhleli weSiza: 2025-06-27 Imvelaphi: Isiza

Buza

I-Joytech yazisa ngokuzingca ukuba i-DBP-6186 kunye ne-6286B yohlobo lwengalo ye-arm-uhlobo oluzenzekelayo oluzenzekelayo olupheleleyo lwedijithali lwe-high blood monitors lufumene i-FDA 510 (k) imvume, ngoku ixhasa i-circumferences yengalo enkulu ukusuka kwi-40cm ukuya kwi-56cm. Yenzelwe abantu abadala kunye nolutsha olungaphezu kweminyaka eyi-12, aba bahloli balinganisa ngokuchanekileyo uxinzelelo lwe-systolic kunye ne-diastolic kunye nesantya se-pulse.

Ixhotyiswe ngemiboniso emikhulu ye-LCD yokufunda lula, izixhobo zinokulungiswa kunye noqhagamshelo lweBluetooth, okwenza kube lula ukulandela umkhondo wezempilo nge-apps eziphathwayo. Inketho entsha ye-cuff enkulu yandisa ukusetyenziswa kubasebenzisi abanobungakanani bengalo enkulu, iqinisekisa imilinganiselo echanekileyo ngaphandle kokungonwabi.

Le mvume ye-FDA iqinisekisa imigangatho ephezulu kunye nokhuseleko lwezixhobo zethu, ukunika ababoneleli bezempilo kunye nabasebenzisi basekhaya ukuguquguquka ngakumbi kunye nokuzithemba ekulawuleni uxinzelelo lwegazi. IJoytech ihleli izibophelele ekuziseni izisombululo ezintsha nezithembekileyo kwiimfuno zempilo zehlabathi.

Ngemibuzo okanye iinkcukacha ezithe vetshe, nceda ungalibazisi fikelela kuthi.