Tinofara kuzivisa kuti mamodhiyo matsva ekutarisa ropa mukati meJoytech Healthcare's iripo chigadzirwa mutsara vakabudirira kuwana FDA 510(k) clearance , zvichitsigira kugadzirira kwavo musika wekuUnited States wemidziyo yekurapa.
Iyo clearance inosimbisa kuti zvishandiso zvinosangana neUS zvinodikanwa zvekuchengetedza uye kuita seKirasi II michina yekurapa , uye yakaenzana zvakanyanya neinotengeswa zviri pamutemo predicate zvishandiso.
Ichangobva Kucheneswa Upper-Arm Blood Pressure Monitor Models
Iwo achangobva kucheneswa mamodheru epamusoro-ruoko otomatiki ekudzivirira kweropa mamonitor akagadzirirwa vashandisi vevakuru vese mudzimba uye munzvimbo dzekiriniki.
Aya mamodheru chikamu cheJoytech Healthcare yakagadzwa yeropa rekutarisa chigadzirwa mutsara , uye kuunza yakagadziridzwa zvigadziriso uye kuyerwa matekinoroji kutsigira yakavandudzwa ruzivo rwevashandisi uye kuyerwa kwekuvimbika.
Ivo vanoshandisa inflation-based blood pressure yekuyera tekinoroji , inogonesa kuyerwa panguva yekukwira kwecuff. Izvi zvinobatsira kuvandudza kuyerwa uye kunyaradza kwemushandisi , uku uchichengeta kuverenga kwakagadzikana uye kwakavimbika.
Yepamberi Monitoring Mabasa eKumba uye Kushandiswa Kwekiriniki
Zvichienderana nekugadziriswa, zvishandiso zvinogona kusanganisira zvinotevera mabasa:
Cuff Tightness Indicator , inotsigira yakakodzera cuff application isati yayera
Yakawandisa Movement Indicator , inobatsira kuvandudza kuyerwa kugadzikana nekuona mafambiro panguva yekushandiswa
AFIB (Atrial Fibrillation) yekuona basa , inotsigira kusajairika kurova kwemoyo kuongorora panguva yekuyera.
MVM basa , ichipa otomatiki avhareji yekuverenga kwakawanda kuti iwedzere kuenderana
Aya mabasa akagadzirirwa kutsigira yakavimbika kutariswa kweropa muhutano hwepamba uye kiriniki yekuongorora mamiriro..
Multiple Cuff Size Configurations
Multiple cuff size configurations iripo, zvinosanganisira 22–36 cm, 22–42 cm, uye 32–48 cm , yakagadzirirwa kugarisa denderedzwa remaoko evakuru vakasiyana uye kuona kuyerwa kwakaringana mumapoka akasiyana-siyana evashandisi.
Zvinokosha Zvigadzirwa
FDA 510 (k) yakabvisa mhando nyowani mukati meiyo iripo yeropa rekutarisa mutsara
Upper-arm automatic blood pressure monitoring system
Inflation-based measurement tekinoroji yekuvandudza kunyaradza uye kugona
Optional Cuff Tightness Indicator yekumisikidza cuff chaiyo
Optional Excessive Movement Indicator yekuona kufamba panguva yekuyera
AFIB yekuona basa rekusagadzikana kurova kwemoyo kuongorora rutsigiro
MVM basa rekuvandudza kuyerwa kuenderana uye kudzokorora
Multiple cuff saizi zvigadziriso zvevashandisi vakuru
Inokodzera kushandiswa kwemba uye kliniki evaluation scenarios
Regulatory Compliance uye Market Readiness
Iyo FDA 510 (k) clearance inoratidza kuzvipira kweJoytech Healthcare mukutevedzwa kwemitemo uye mhando yechigadzirwa kumisika yepasi rose yehutano, kusanganisira United States.
Iwo anoenderana 510(k) manhamba anowanikwa pachena uye anooneswa muFDA dhatabhesi , kuve nechokwadi chekujeka uye kuteedzera.
Kudyidzana Mikana yeVatengi uye OEM/ODM Vatengi
Aya mamodheru achangobva kucheneswa anowanikwa kuti aongororwe nevashambadziri vemidziyo yekurapa, vanotenga kunze kwenyika, uye vadyidzani veOEM/ODM vari kutsvaga mhinduro dzinoenderana neropa rekutarisa misika yavo.
Isu tinogashira kubatirana pamwe nevadyidzani vanofarira kuongororwa kwechigadzirwa, kuvandudzwa kwemazita epachivande, uye rutsigiro rwekutumira musika kugovera pasi rose.
Nezve Joytech Healthcare
Joytech Healthcare inyanzvi inogadzira zvehutano hwepamba nemidziyo yekutarisa yekurapa, inyanzvi mukutarisa kweropa, mathermometers, pulse oximeters, nebulizers, pombi dzezamu uye zvimwe zvigadzirwa zvehutano.
Isu tinopa OEM / ODM yezvokurapa mudziyo mhinduro epasi rose ehutano mhando, vagovanisi, uye vatinoshanda navo, tichitarisa kuteedzera kwemitemo, kuvimbika kwechigadzirwa, uye kushandira pamwe kwenguva refu.
Zvechigadzirwa chekuongorora samples, zvinyorwa zvehunyanzvi, kana kubatana zvine chekuita neyedu FDA 510 (k) yakacheneswa BP yekutarisa mhando, ndapota taura nechikwata chedu.
