Matanhatu ekumusoro-ruoko otomatiki eropa mamonitor kubva kuJoytech Healthcare's DBP Plus akatevedzana akapihwa FDA 510 (k) mvumo pasi peK261394, ichigonesa kushambadzira mumusika weUS.
Kune mhando dzehutano uye vagovani vanoshanda mumusika weUS, kubvumidzwa uku kunopfuura chiitiko chekutonga - chinhu chinoshanda chekupinda mumusika. Chishandiso chega chega chakacheneswa chakaongororwa seKirasi II mudziyo wekurapa uye wakawanikwa wakaenzana zvakanyanya nezvinotengeswa zviri pamutemo zvirevo, nechinangwa chekushandisa chinofukidza ruzhinji.
Mutsara Wakajeka WemaModheru Matanhatu
DBP Plus akatevedzana anounza mamodheru matsva matanhatu muJoytech Healthcare's US-yakacheneswa portfolio: DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, uye DBP-62E2B Plus.
Imwe neimwe modhi ndeye otomatiki zvizere Upper-arm blood pressure monitor yakavakirwa kuyera zuva nezuva kumba. Iyo nhevedzano inoenderera zvakare neyakasimbiswa yekutonga mutsara - dzakatangira DBP-6186 uye DBP-6286B dzakacheneswa neFDA muna 2025 kune vashandisi vane maoko akakura, uye chizvarwa chePlus chinotambanudzira iyo imwechete engineering chikuva kune yakakura modhi renji.
Makumi maviri eCuff, Yakakura Mushandisi Kufukidza
Yese modhi mubatch inogadziriswa neimwe yesarudzo mbiri dzecuff - yakajairwa 22-42 cm cuff kana yakawedzera 40-56 cm hombe ruoko cuff.
Iyi nzira yehuviri-cuff inokosha mune zvekutengeserana zvakanyanya sekiriniki. Inobvumira zvirongwa zvekutengesa uye vatengi vemasangano kuti vavake saizi-inosanganisirwa assortments kubva kune imwechete yakacheneswa chigadzirwa mhuri, kuitira kuti vanhu vakuru vane maoko anowira kunze kweakajairwa cuff renji havachamanikidzwa mukuyero zviyero.
Iko Aya Mamonitor Anokwana muUS Portfolio
Kune vatengi vanoongorora DBP Plus akatevedzana, mapoinzi matatu anomira pachena:
Iyo yakazara-modhi mitanhatu batch yakafukidzwa neiyo FDA 510 (k) kubvumidzwa, saka kuronga kweassortment kunogona kuenderera pasina imwe-yemhando yekudzora gapu.
Ese ari maviri akajairwa uye makuru ruoko cuff shanduro anowanikwa mukati meakacheneswa scope.
Chiratidzo chehuwandu hwehuwandu chinotsigira huwandu hwakawanda hwemikana yekugovera yeUS, inosanganisira zvitoro, e-commerce, uye mamwe nzira dzehutano.
Rekodhi rekodhi pachayo rinogona kusimbiswa nevadyidzani panguva yakafanira - iyo K261394 pfupiso inowanikwa pachena kuburikidza neiyo FDA dhatabhesi.
Yakavakwa pane Yakasimbiswa Regulatory Track Record
Iyi denderedzwa yemvumo inowedzera kune kukura kweUS kuteedzera portfolio kuJoytech Healthcare, iyo inotosanganisira yakapfuura 510 (k) kubvumidzwa kweropa rekutarisa BP uye yeropa rekutarisa masisitimu, padivi peEC yekumaka pasi peEU MDR, ISO 13485 certification, uye MDSAP kutevedzera.
Kune veOEM/ODM vanobatirana navo, iyo rekodhi rekodhi inopfupisa nhaurirano yekuteerera: mubvunzo unotama kubva pakuti mugadziri anogona kuzadzisa zvinodiwa neUS kune iyo modhi yekumisikidza inokodzera chirongwa.
Inowanikwa Kugovera uye OEM/ODM Zvirongwa
Joytech Healthcare parizvino iri kugamuchira kubvunza kubva kuUS vagovani vezvishandiso zvekurapa, vanotenga kunze kwenyika, uye vadyidzani vemhando vanofarira DBP Plus nhevedzano - kusanganisira yakavanzika-label kuvandudza, tsika kurongedza, uye zvinyorwa zvinotsigira kunyoresa musika.
Nezve Joytech Healthcare
Joytech Healthcare inyanzvi inogadzira zvehutano hwepamba uye michina yekutarisa yekurapa, inyanzvi mune eropa mamonitor, thermometers, pulse oximeters, nebulizers, mazamu pombi uye zvimwe zvigadzirwa zvehutano.
Tinopa OEM/ODM zvigadziriso zvemishonga zvekurapa zvepasi rose zvehutano mhando, vanogovanisa, uye vanobatirana navo, vachitarisa pakutevedza kwemitemo, kuvimbika kwechigadzirwa, uye kushandira pamwe kwenguva refu.
Kukumbira masampuli ekuongorora, zvinyorwa zvemvumo, kana kotesheni yeDBP Plus nhevedzano, svika kuchikwata chedu pa. sale14@sejoy.com - kana bhurawuza yakazara FDA 510(k) yakacheneswa BP yekutarisa mutsara pane yedu webhusaiti.
