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Ekhaya » Iindaba » Product Insights » Ukhathalelo lwezempilo lweJoytech Iimodeli ezitsha zokuJonga uxinezeleko lweGazi ziFumana i-FDA 510(k) iCwangciso

IJoytech Healthcare Iimodeli ezitsha zeMoni yoxinzelelo lwegazi ziFumana i-FDA 510(k) Usulelo

Iimboniselo: 0     uMbhali: Ixesha lokupapasha loMhleli weSiza: 2026-05-05 Imvelaphi: Isiza

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Siyavuya ukwazisa ukuba iimodeli ezintsha zokujonga uxinzelelo lwegazi ngaphakathi komgca wemveliso okhoyo weJoytech Healthcare ufumene ngempumelelo imvume ye-FDA 510(k) , exhasa ukulungela kwabo imakethi yezixhobo zonyango zase-United States.

Ukukhutshwa kuqinisekisa ukuba izixhobo zihlangabezana neemfuno zokulawula zase-US zokhuseleko kunye nokusebenza njengezixhobo zonyango lwe-Class II , kwaye zilingana kakhulu nezixhobo ezithengiswayo ngokusemthethweni.

IiModeli zokuJonga ukuJonga uxinezeleko lweGazi esandula kuCociswa Upper-Arm

Iimodeli ezisandula ukucocwa zizijongi zoxinzelelo lwegazi ezizenzekelayo ezilungiselelwe abasebenzisi abadala ngokubanzi kuzo zombini iimeko zasekhaya kunye nekliniki.

Le mizekelo iyingxenye ye-Joytech Healthcare esekelwe kumgca wemveliso yoxinzelelo lwegazi , kwaye yazisa ulungelelwaniso oluhlaziyiweyo kunye nobuchwepheshe bokulinganisa ukuxhasa amava omsebenzisi aphuculweyo kunye nokuthembeka kokulinganisa.

Basebenzisa itekhnoloji yokulinganisa uxinzelelo lwegazi esekelwe ekunyukeni kwamaxabiso , evumela umlinganiselo ngexesha lokunyuka kwamaxabiso e-cuff. Oku kunceda ukuphucula ukusebenza komlinganiselo kunye nokuthuthuzela komsebenzisi , ngelixa ugcina ukufundwa okuzinzile nokuthembekileyo.

ImiSebenzi yokuHlola ePhambili yokuSetyenziswa kweKhaya kunye neKlinikhi

Ngokuxhomekeke kubumbeko, izixhobo zinokubandakanya le misebenzi ilandelayo:

  • I-Cuff Tightness Indicator , exhasa isicelo esifanelekileyo se-cuff ngaphambi kokulinganisa

  • Isalathisi sokuhamba ngokugqithisileyo , ukunceda ukuphucula ukuzinza kokulinganisa ngokufumanisa ukunyakaza ngexesha lokusetyenziswa

  • I-AFIB (i-Atrial Fibrillation) umsebenzi wokufumanisa , ukuxhasa ukuhlolwa kwentliziyo engaqhelekanga ngexesha lokulinganisa

  • Umsebenzi we-MVM , ukubonelela nge-avareji ezenzekelayo yofundo oluninzi ukwenzela ukuhambelana okuphuculweyo

Le misebenzi yenzelwe ukuxhasa iliso elithembekileyo loxinzelelo lwegazi kuzo zombini ukhathalelo lwezempilo lwasekhaya kunye neemeko zovavanyo lweklinikhi..

Uqwalaselo lobungakanani beCuff ezininzi

Ulungelelwaniso lwesayizi yecuff ezininzi luyafumaneka, kubandakanywa i-22-36 cm, 22-42 cm, kunye ne-32-48 cm , eyilelwe ukujongana neesangqa zengalo zabantu abadala ezahlukeneyo kunye nokuqinisekisa umlinganiselo ochanekileyo kumaqela ahlukeneyo abasebenzisi.

Iimpawu eziphambili zeMveliso

  • I-FDA 510(k) icoce imifuziselo emitsha kumgca okhoyo wokubeka iliso woxinzelelo lwegazi

  • Upper-arm oluzenzekelayo inkqubo esweni uxinzelelo lwegazi

  • Itekhnoloji yokulinganisa i-inflation esekelwe ekuphuculeni induduzo kunye nokusebenza kakuhle

  • Isalathisi sokuQiniswa kweCuff esiKhethekileyo sokubekwa ngokufanelekileyo kwe-cuff

  • Isalathisi sokuhamba ngokuKhethekileyo esiKhethekileyo sokubonwa kwentshukumo ngexesha lokulinganisa

  • Umsebenzi wokubona i-AFIB yokuxhasa ukubetha kwentliziyo engaqhelekanga

  • Umsebenzi we-MVM wokuphucula ukuhambelana komlinganiselo kunye nokuphindaphinda

  • Ulungelelwaniso lwesayizi yecuff ezininzi kubasebenzisi abadala

  • Ilungele ukusetyenziswa kwekhaya kunye neemeko zovavanyo lweklinikhi

Ukuthotyelwa koLawulo kunye nokuLungela iMarike

Ukukhutshwa kwe-FDA 510 (k) kubonisa ukuzibophelela kweJoytech Healthcare ekuthotyelweni kokulawula kunye nomgangatho wemveliso kwiimarike zezempilo zehlabathi, kuquka ne-United States.

Amanani angama-510(k) ahambelanayo afumaneka esidlangalaleni kwaye ayaqinisekiswa kwisiseko sedatha se-FDA , ukuqinisekisa ukungafihli kunye nokulandeleka.

Amathuba okuBambisana aBasasazi kunye nabaThengi be-OEM/ODM

Ezi modeli zisanda kususwa ziyafumaneka ukuze zihlolwe ngabasasazi bezixhobo zonyango, abarhwebi, kunye namaqabane e-OEM/ODM afuna izisombululo ezithobelayo zokuhlola uxinzelelo lwegazi kwiimarike zabo.

Siyayamkela intsebenziswano namahlakani anomdla ekuvavanyeni imveliso, uphuhliso lweeleyibhile zabucala, kunye nenkxaso yokusasazwa kweemarike zokusasazwa kwehlabathi.

Malunga Joytech Healthcare

Joytech Healthcare ngumvelisi oqeqeshiweyo wokhathalelo lwezempilo lwasekhaya kunye nezixhobo zokubeka iliso zonyango, okhethekileyo kwiimonitha zoxinzelelo lwegazi, i-thermometers, i-pulse oximeters, i-nebulizers, iimpompo zamabele kunye nezinye iimveliso zempilo.

Sibonelela OEM/ODM izisombululo isixhobo zonyango ngeempawu zokhathalelo lwempilo zehlabathi, abasasazi, kunye namaqabane, sigxile ekuthotyelweni kolawulo, ukuthembeka kwemveliso, kunye nentsebenziswano yexesha elide.

Qhagamshelana nathi

Ngeesampuli zovavanyo lwemveliso, amaxwebhu obugcisa, okanye intsebenziswano malunga neyethu I-FDA 510(k) icociwe iimodeli zokujonga uxinzelelo lwegazi , nceda uqhagamshelane neqela lethu.

 NO.365, iWuzhou Road, Hangzhou, kwiPhondo laseZhejiang, 311100, China

 No.502, Shunda Road, Hangzhou, iPhondo Zhejiang, 311100, China
 

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