Wona mɔɖeɖe le abɔta ƒe ʋu ƒe sisi le wo ɖokui si tso Joytech Healthcare ƒe DBP Plus series me le FDA 510(k) ƒe mɔɖeɖe te le K261394 te, si na woate ŋu adzra wo le United States ƒe asi me.
Le lãmesẽnyawo gbɔ kpɔkpɔ ƒe adzɔnuwo kple mamalawo siwo le dɔ dzi le United States ƒe asi me gome la, mɔɖeɖe sia de ŋgɔ wu sedede ƒe nu vevi aɖe ko — enye asitsatsa ƒe gege ɖe eme ƒe mɔnukpɔkpɔ ŋutɔŋutɔ. Woto mɔ̃ ɖesiaɖe si woɖe ɖa me be enye atikewɔmɔ̃ ƒe hatsotso II eye wokpɔe be esɔ kple nyagbɔgblɔ siwo wodzrana le se nu ŋutɔ, eye wozãe si woɖo be woazã la axɔ amehawo katã.
Kpɔɖeŋu Yeye Ade ƒe Ðoɖo si Me Kɔ
DBP Plus ƒe ƒuƒoƒoa tsɔ ʋu yeye ade va Joytech Healthcare ƒe agbalẽdzraɖoƒe si United States kɔ: DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, kple DBP-62E2B Plus.
Mɔ̃ ɖesiaɖe nye esi wowɔna le eɖokui si bliboe abɔta ƒe ʋu ƒe sisidzidzenu si wotu hena aƒeme dzidzedze gbesiagbe. Nusiwo kplɔ wo nɔewo ɖo hã yi edzi le ɖoɖowɔɖi ƒe dzidzime si ŋu kpeɖodzi le dzi — FDA ɖe asi le esiwo do ŋgɔ nɛ DBP-6186 kple DBP-6286B ŋu le ƒe 2025 me na ezãla siwo si alɔ gãwo le, eye Plus dzidzimea keke mɔ̃ɖaŋununya ƒe mɔnu ma ke ɖe enu wòɖo mɔ̃ siwo keke ta wu.
Cuff ƒe Agbɔsɔsɔ Eve, Zãla ƒe Kpekpeɖeŋu si Keke Wu
Woɖo kpɔɖeŋu ɖesiaɖe le batch la me kple cuff tiatia eve dometɔ ɖeka — cuff si wozãna ɖaa si ƒe didime nye 22–42 cm alo alɔnu gã si keke sentimeta 40–56.
Mɔnu sia si me wozãa asibidɛ eve le la le vevie le asitsatsa gome abe alesi wòle vevie le atikewɔnyawo gome ene. Enaa asitsaɖoɖowo kple dɔwɔƒewo ƒe nuƒlelawo te ŋu tua nu vovovo siwo ƒe lolome hã le tso adzɔnuwo ƒe ƒome ɖeka si me woɖe asi le me, ale be womegazi ame tsitsi siwo ƒe abɔwo ge ɖe asibide ƒe didime siwo wozãna ɖaa godo dzi be woawɔ nugblẽfexexe ƒe dzidzenuwo o.
Afisi Monitor Siawo Sɔ Le United States ƒe Dɔwɔƒe aɖe
Le nuƒlela siwo le DBP Plus ƒe hatsotsoawo me tom gome la, nya etɔ̃ ɖe dzesi:
Wotsɔ FDA 510(k) ƒe mɔɖeɖe ɖeka xea nu tso kpɔɖeŋu ade ƒe hatsotso bliboa ŋu, eyata ɖoɖowɔwɔ ɖe hatsotso vovovowo ŋu ate ŋu ayi edzi vovototo aɖeke manɔmee le kpɔɖeŋu ɖesiaɖe ƒe ɖoɖowɔwɔ me.
Abɔta ƒe asigɛ siwo wozãna ɖaa kple esiwo lolo siaa li le afisi woɖe asi le.
Amewo ƒe agbɔsɔsɔ bliboa ƒe dzesi doa alɔ United States ƒe mama ƒe mɔnukpɔkpɔ gbogbo aɖewo, siwo dometɔ aɖewoe nye asitsatsa, asitsatsa to kɔmpiuta dzi, kple lãmesẽnyawo gbɔ kpɔkpɔ ƒe mɔnu bubuwo.
Woateŋu aɖo kpe ɖaseɖigbalẽa ŋutɔ dzi le hadɔwɔlawo gbɔ le veviedodonu si sɔ me — K261394 ƒe nyatakaka kpui la le dutoƒo to FDA ƒe nyatakakadzraɖoƒea dzi.
Wotue ɖe Sedziwɔwɔ ƒe Nuŋlɔɖi si Woɖo anyi Dzi
Mɔɖeɖewo ƒe ɣeyiɣi sia kpe ɖe United States ƒe sedziwɔwɔ ƒe ɖoɖo si le dzidzim ɖe edzi le Joytech Healthcare ŋu, si me mɔɖeɖe siwo wowɔ do ŋgɔ le 510(k) me xoxo na ʋu ƒe sisi dzikpɔlawo kple ʋumesukli dzi kpɔkpɔ ƒe ɖoɖowo, tsɔ kpe ɖe CE dzesidede le EU MDR, ISO 13485 ƒe ɖaseɖigbalẽ, kple MDSAP ƒe sedziwɔwɔ te ŋu.
Le OEM/ODM hadɔwɔlawo gome la, nuŋlɔɖi ma naa dzeɖoɖo si ku ɖe sedziwɔwɔ ŋu la nɔa kpuie: biabia la trɔna tso nenye be adzɔnuwɔƒea ate ŋu aɖo United States ƒe nudidiwo gbɔ na kpɔɖeŋu ƒe ɖoɖo si sɔ ɖe ɖoɖowɔɖia nu.
Woate ŋu awɔe na Mama kple OEM/ODM Ðoɖowo
Joytech Healthcare le nyabiasewo xɔm fifia tso United States ƒe atikewɔnuwo mamalawo, nusiwo wotsɔ tso duta vɛ, kple adzɔnu ƒe ŋkɔ ƒe hadɔwɔla siwo tsɔ ɖe le DBP Plus ƒe xexlẽdzesiwo me — siwo dometɔ aɖewoe nye ame ŋutɔ ƒe ŋkɔ ƒe ŋgɔyiyi, nubablɛ siwo wowɔ ɖe ɖoɖo nu, kple nuŋlɔɖiwo ƒe kpekpeɖeŋu na asi ƒe ŋkɔ dede agbalẽ me.
Ku ɖe Joytech Lãmesẽnyawo Gbɔkpɔha ŋu
Joytech Healthcare nye aƒeme lãmesẽnyawo gbɔ kpɔkpɔ kple atikewɔwɔ ƒe ŋkuléleɖenuŋumɔ̃wo wɔla bibi aɖe, si bi ɖe ʋu ƒe sisidzidzenuwo, dzoxɔxɔdzidzenuwo, ʋu ƒe sisidzidzenuwo, nebulizers, no me pɔmpiwo kple lãmesẽnyawo gbɔ kpɔkpɔ ƒe atike bubuwo me.
Míenaa nu OEM/ODM atikewɔnuwo gbɔkpɔnu na xexeame katã ƒe lãmesẽnyawo gbɔ kpɔkpɔ ƒe adzɔnuwo, mamalawo, kple hadɔwɔlawo, si léa fɔ ɖe sedziwɔwɔ, adzɔnuwo ƒe kakaɖedzi, kple nuwɔwɔ aduadu ɣeyiɣi didi ŋu.
Ne èdi be yeabia be yeaxɔ dodokpɔ ƒe kpɔɖeŋuwo, clearance documents, alo quotation na DBP Plus series la, te ɖe míaƒe ƒuƒoƒoa ŋu le sale14@sejoy.com — alo nàdzro FDA 510(k) ƒe ʋu ƒe sisi ƒe ŋkuléleɖenuŋu ƒe ɖoɖo bliboa me le míaƒe nyatakakadzraɖoƒea.
