Mawonedwe: 0 Wolemba: Site Editor Nthawi Yosindikiza: 2026-05-05 Koyambira: Tsamba
Ndife okondwa kulengeza kuti mitundu yatsopano yowunikira kuthamanga kwa magazi mkati mwa mzere wa mankhwala omwe alipo a Joytech Healthcare apeza chilolezo cha FDA 510(k) , kuchirikiza kukonzekera kwawo msika wa zida zamankhwala ku United States.
Chilolezocho chimatsimikizira kuti zidazo zimakwaniritsa zofunikira zoyendetsera US pachitetezo ndi magwiridwe antchito monga zida zachipatala za Gulu Lachiwiri , ndipo ndizofanana kwambiri ndi zida zomwe zimagulitsidwa mwalamulo.
Mitundu yatsopanoyi ndi yowunikira kuthamanga kwa magazi yomwe imapangidwira anthu akuluakulu kunyumba komanso kuchipatala.
Zitsanzozi ndi gawo la mzere wa mankhwala a Joytech Healthcare omwe adakhazikitsidwa ndi kuthamanga kwa magazi , ndipo amayambitsa masinthidwe osinthidwa ndi matekinoloje oyezera kuti athandizire luso la wogwiritsa ntchito komanso kudalirika kwa kuyeza.
Amagwiritsa ntchito ukadaulo woyezera kuthamanga kwa magazi motengera kukwera kwa inflation , zomwe zimathandiza kuyeza panthawi ya inflation. Izi zimathandizira kuwongolera magwiridwe antchito komanso chitonthozo cha ogwiritsa ntchito , ndikusunga zowerengera zokhazikika komanso zodalirika.
Kutengera kasinthidwe, zida zitha kukhala ndi izi:
Chizindikiro cha Cuff Tightness , chothandizira kugwiritsa ntchito makafu moyenera musanayese
Chizindikiro cha Movement Movement , kuthandizira kukonza kukhazikika kwa muyeso pozindikira kuyenda pakagwiritsidwe ntchito
AFIB (Atrial Fibrillation) ntchito yozindikira , kuthandizira kuyesa kugunda kwa mtima kosakhazikika pakuyezera.
Ntchito ya MVM , yopereka mawerengedwe owerengeka angapo kuti azitha kusinthasintha
Ntchitozi zidapangidwa kuti zithandizire kuwunika kodalirika kwa kuthamanga kwa magazi m'zochitika zachipatala komanso zowunikira..
Makasinthidwe a kukula kwa makapu angapo akupezeka, kuphatikiza 22-36 cm, 22-42 cm, ndi 32-48 cm , opangidwa kuti athe kutengera ma circumferences aakulu akulu ndikuwonetsetsa kuyeza kolondola pamagulu osiyanasiyana ogwiritsa ntchito.
FDA 510(k) yachotsa mitundu yatsopano mkati mwa mzere womwe ulipo wowunika kuthamanga kwa magazi
Upper-arm automatic blood pressure monitoring system
Tekinoloje yoyezera kukwera kwa inflation kuti mutonthozedwe bwino komanso mogwira mtima
Chizindikiritso cha Cuff Kulimba Kwamakhalidwe oyenera
Chizindikiritso cha Movement Excessive Movement kuti muzindikire zoyenda panthawi yoyezera
Kuzindikira kwa AFIB kwa chithandizo chosakhazikika cha kugunda kwa mtima
Ntchito ya MVM pakuwongolera kusinthasintha kwa kuyeza komanso kubwereza
Zosintha zingapo za kukula kwa makafu kwa ogwiritsa ntchito akuluakulu
Zoyenera kugwiritsidwa ntchito kunyumba komanso zochitika zowunikira
Chilolezo cha FDA 510(k) chikuwonetsa kudzipereka kwa Joytech Healthcare pakutsata malamulo ndi mtundu wazinthu zamisika yapadziko lonse lapansi, kuphatikiza United States.
Nambala zofananira za 510(k) zimapezeka poyera ndipo zimatsimikiziridwa munkhokwe ya FDA , kuwonetsetsa kuti zikuwonekera komanso kutsata.
Mitundu yatsopanoyi ikupezeka kuti iwunikidwe ndi ogawa zida zamankhwala, otumiza kunja, ndi othandizana nawo a OEM/ODM omwe akufuna njira zowunikira kuthamanga kwa magazi pamisika yawo.
Tikulandila mgwirizano ndi othandizana nawo omwe ali ndi chidwi ndi kuwunika kwazinthu, kukulitsa zilembo zachinsinsi, ndikuthandizira kutumiza msika kuti zigawidwe padziko lonse lapansi.
Joytech Healthcare ndi katswiri wopanga zithandizo zachipatala zakunyumba ndi zida zowunikira zamankhwala, okhazikika pazowunikira kuthamanga kwa magazi, ma thermometers, pulse oximeters, nebulizers, mapampu am'mawere ndi zinthu zina zamankhwala.
Timapereka Mayankho a zida zachipatala za OEM/ODM mitundu yazaumoyo padziko lonse lapansi, ogawa, ndi othandizana nawo, kuyang'ana kwambiri kutsata malamulo, kudalirika kwazinthu, komanso mgwirizano wanthawi yayitali.
Kwa zitsanzo zowunikira zinthu, zolemba zaukadaulo, kapena mgwirizano wokhudzana ndi zathu FDA 510(k) yochotsa zitsanzo zowunikira kuthamanga kwa magazi , chonde lemberani gulu lathu.