Izijongi zoxinzelelo lwegazi ezintandathu ezizenzekelayo ezisuka kwiJoytech Healthcare's DBP Plus ziye zanikwa imvume ye-FDA 510(k) phantsi kwe-K261394, eyenza urhwebo kwimarike yase-US.
Kwiimpawu zokhathalelo lwempilo kunye nabasasazi abasebenzayo kwimarike yase-US, olu xwebhu lungaphezulu kwenqanaba lolawulo - yinto esebenzayo yokungena kwimarike. Isixhobo ngasinye esicociweyo siye sajongwa njengesixhobo sonyango soMgangatho wesibini saza safunyanwa silingana kakhulu nezibhengezo ezithengiswayo ngokusemthethweni, ngenjongo yokusetyenziswa okujoliswe kuluntu ngokubanzi.
Uluhlu olucacileyo lweeModeli eziNtsha ezintandathu
I-series ye-DBP Plus izisa iimodeli ezintsha ezintandathu kwi-portfolio ye-Joytech Healthcare yase-US: DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, kunye ne-DBP-62E2B Plus.
Imodeli nganye izenzekelayo ngokupheleleyo Imonitha yoxinzelelo lwegazi ephezulu yengalo eyakhelwe ukulinganisa ekhaya imihla ngemihla. Olu ngcelele luqhubela phambili nomnombo wolawulo oqinisekisiweyo - abanduleli bayo DBP-6186 kunye DBP-6286B zacinywa yi-FDA ngo-2025 kubasebenzisi iingalo ezinkulu, kunye nesizukulwana Plus ukwandisa ukuba iqonga lobunjineli efanayo kuluhlu olubanzi imodeli.
Iisayizi ezimbini zeCuff, uFundo oluBanzi lwabasebenzisi
Yonke imodeli kwibhetshi iqwalaselwe enye yeenketho ezimbini zecuff - icuff eqhelekileyo ye-22-42 cm okanye i-cuff enkulu yengalo ye-40-56 cm.
Le ndlela ye-double-cuff ibalulekile kurhwebo njengakwikliniki. Ivumela iinkqubo zokuthengisa kunye nabathengi bamaziko ukuba bakhe ii-assortments ezibandakanya ubungakanani ukusuka kusapho lwemveliso ecociweyo, ukuze abantu abadala abazandla zabo ziphume ngaphandle koluhlu lwe-cuff oluqhelekileyo abasayi kunyanzeliswa kwimilinganiselo yokulalanisa.
Apho ezi Mhloli zingena kwiPotfoliyo yase-US
Kubathengi abavavanya uthotho lweDBP Plus, amanqaku amathathu agqamile:
Ibhetshi epheleleyo yeemodeli ezintandathu igutyungelwe yi-FDA 510(k) imvume, ngoko ke ukucwangciswa kwe-assortment kunokuqhubeka ngaphandle kwezithuba zolawulo lwemodeli nganye.
Zombini iinguqulelo ezisemgangathweni nezinkulu zekhafu yengalo ziyafumaneka ngaphakathi komda ocoliweyo.
Isalathiso sabemi ngokubanzi sixhasa uluhlu olubanzi lwamathuba okuhanjiswa kwe-US, kubandakanywa ukuthengisa, i-e-commerce, kunye nezinye iindlela zempilo.
Irekhodi yokucoca ngokwayo inokuqinisekiswa ngamaqabane ngexesha lokunyamekela - isishwankathelo se-K261394 sifumaneka esidlangalaleni ngokusebenzisa i-database ye-FDA.
Yakhelwe kwiRekhodi eMiselweyo yoLawulo lweNdlela yoLawulo
Lo mjikelo wokucocwa kongeza kwipotfoliyo yokuthotyelwa kwe-US ekhulayo kwi-Joytech Healthcare, esele ibandakanya i-510 (k) yangaphambili yokukhutshwa kwe-blood monitors kunye neenkqubo zokubeka iliso kwi-blood glucose, kunye nokumakishwa kwe-CE phantsi kwe-EU MDR, isatifikethi se-ISO 13485, kunye nokuthotyelwa kwe-MDSAP.
Kumahlakani e-OEM/ODM, loo rekhodi imfutshane yenza mfutshane incoko yothotyelo: umbuzo uyasuka ekubeni ngaba umenzi angahlangabezana neemfuno zase-US ukuba loluphi uqwalaselo olungena inkqubo.
Iyafumaneka kwi-Distribution kunye neeNkqubo ze-OEM/ODM
I-Joytech Healthcare ngoku iyamkela imibuzo evela kubanikezeli bezixhobo zonyango zase-US, abathumeli bangaphandle, kunye namaqabane e-brand anomdla kwi-DBP Plus series - kubandakanywa nophuhliso lwelebula yangasese, ukupakishwa kwesiko, kunye nenkxaso yamaxwebhu okubhaliswa kweemarike.
Malunga Joytech Healthcare
I-Joytech Healthcare ngumvelisi oqeqeshiweyo wezempilo zasekhaya kunye nezixhobo zokubeka iliso zonyango, ngokukodwa kwiimonitha zoxinzelelo lwegazi, i-thermometers, i-pulse oximeters, i-nebulizers, iimpompo zamabele kunye nezinye iimveliso zempilo.
Siyabonelela Izisombululo zesixhobo sonyango se-OEM/ODM kwiimpawu zokhathalelo lwempilo zehlabathi, abasasazi, kunye namaqabane, kugxininise ekuthotyelweni kolawulo, ukuthembeka kwemveliso, kunye nentsebenziswano yexesha elide.
Ukucela iisampulu zovavanyo, amaxwebhu okukhutshwa, okanye ikowuti yoluhlu lwe-DBP Plus, fikelela kwiqela lethu ku. sale14@sejoy.com - okanye ukhangele i-FDA 510(k) ecociweyo yokubeka iliso kwiwebhusayithi yethu.
