Iziqapha zomfutho wegazi ezizenzakalelayo eziyisithupha eziphuma phezulu ezivela ochungechungeni lwe-DBP Plus lwe-Joytech Healthcare zinikezwe imvume ye-FDA 510(k) ngaphansi kwe-K261394, okuvumela ukuhweba emakethe yase-US.
Kumabhrendi okunakekelwa kwezempilo nabasabalalisi abasebenzayo emakethe yase-US, le mvume ingaphezu kwengqophamlando yokulawula - iwumthombo osebenzayo wokungena emakethe. Idivayisi ngayinye esuliwe iye yabuyekezwa njengedivayisi yezokwelapha Yesigaba II futhi yatholwa ilingana kakhulu nezilandiso ezimakethwe ngokusemthethweni, ngokusetshenziswa okuhlosiwe okuhlanganisa abantu abaningi.
Uhlu Olusuliwe lwamamodeli amasha ayisithupha
Uchungechunge lwe-DBP Plus luletha amamodeli amasha ayisithupha kuphothifoliyo esulwe yi-Joytech Healthcare yase-US: DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, kanye ne-DBP-62E2B Plus.
Imodeli ngayinye iyi-othomathikhi ngokugcwele Umshini wokuqapha umfutho wegazi ophezulu wengalo eyakhelwe ukukala ekhaya nsuku zonke. Lolu chungechunge luphinde luqhubeke nohlu lokulawula olufakazelwe - ezandulele zayo i-DBP-6186 kanye ne-DBP-6286B zasulwa yi-FDA ngo-2025 kubasebenzisi abanezingalo ezinkudlwana, futhi isizukulwane se-Plus sinweba leyo nkundla yobunjiniyela efanayo ebangeni elibanzi lamamodeli.
Osayizi Be-Cuff Ababili, Ukufakwa Okubanzi Kwabasebenzisi
Yonke imodeli eqeqebeni ihlelwa ngenye yezinketho ezimbili ze-cuff - i-cuff evamile engu-22-42 cm noma inkomishi yengalo enkulu enwetshiwe engu-40-56 cm.
Le ndlela ye-double cuff ibalulekile kwezohwebo nangokwezempilo. Ivumela izinhlelo zokudayisa kanye nabathengi bezikhungo ukuthi bakhe ama-assortment ahlanganisa usayizi osuka kumndeni owodwa womkhiqizo osuliwe, ukuze abantu abadala izingalo zabo ezingaphandle kobubanzi be-cuff obujwayelekile bangabe besaphoqelelwa ekulinganisweni kobungozi.
Lapho Lezi Ziqaphi Zilingana Kuphothifoliyo Yase-US
Kubathengi abahlola uchungechunge lwe-DBP Plus, amaphuzu amathathu agqamile:
Iqoqo eligcwele lamamodeli ayisithupha limbozwe imvume eyodwa ye-FDA 510(k), ngakho ukuhlela okunezinhlobonhlobo kungaqhubeka ngaphandle kwezikhala zokulawula zemodeli ngayinye.
Zombili izinguqulo ezijwayelekile nezinkulu zekhafu yengalo ziyatholakala ngaphakathi kwesikophu esisuliwe.
Inkomba evamile yabantu isekela ububanzi obubanzi bamathuba okusabalalisa ase-US, okuhlanganisa ukuthengisa, i-e-commerce, nezinye iziteshi zokunakekelwa kwezempilo.
Irekhodi lokugunyazwa ngokwalo lingaqinisekiswa ozakwethu ngesikhathi sokukhuthala okufanele - isifinyezo se-K261394 sifinyeleleka esidlangalaleni ngesizindalwazi se-FDA.
Yakhelwe Kurekhodi Elimisiwe Lethrekhi Yokulawula
Lo mzuliswano wokugunyazwa wengeza kwiphothifoliyo ekhulayo yase-US yokuthobela kwaJoytech Healthcare, esevele ihlanganisa imvume yangaphambilini engu-510(k) yeziqaphi zomfutho wegazi nezinhlelo zokuqapha ushukela wegazi, kanye nokumaka i-CE ngaphansi kwe-EU MDR, isitifiketi se-ISO 13485, nokuthobela i-MDSAP.
Kozakwethu be-OEM/ODM, lelo rekhodi lifinyeza ingxoxo yokuthobelana: umbuzo uyasuka kokuthi ingabe umkhiqizi angakwazi yini ukuhlangabezana nezimfuneko zase-US ukuthi iyiphi imodeli yokucushwa elingana nohlelo.
Itholakalela Ukusabalalisa kanye Nezinhlelo ze-OEM/ODM
I-Joytech Healthcare njengamanje yamukela imibuzo evela kubasabalalisi bemishini yezokwelapha yase-US, abangenisi, kanye nozakwethu bomkhiqizo abanentshisekelo ochungechungeni lwe-DBP Plus - okuhlanganisa ukuthuthukiswa kwelebula yangasese, ukupakisha ngokwezifiso, nokusekelwa kwemibhalo yokubhaliswa kwemakethe.
Mayelana neJoytech Healthcare
IJoytech Healthcare ingumkhiqizi ochwepheshile wokunakekelwa kwempilo yasekhaya kanye namadivayisi okuqapha ezokwelapha, osebenza ngokukhethekile kumamonitha womfutho wegazi, ama-thermometers, ama-pulse oximeters, ama-nebulizers, amaphampu wamabele neminye imikhiqizo yokunakekelwa kwezempilo.
Sihlinzeka Izixazululo zedivayisi yezokwelapha ye-OEM/ODM yamabhrendi okunakekelwa kwezempilo emhlabeni wonke, abasabalalisi, nozakwethu, okugxile ekuthobeleni imithetho, ukwethembeka komkhiqizo, nokubambisana kwesikhathi eside.
Ukuze ucele amasampula okuhlaziya, imibhalo yemvume, noma ikhotheshini yochungechunge lwe-DBP Plus, finyelela ithimba lethu ku- sale14@sejoy.com — noma upheqa i-FDA 510(k) ephelele esuliwe yokuqapha umfutho wegazi kuwebhusayithi yethu.
