Siks ɔpa-am ɔtomɛtik blɔd prɛshɔn monita frɔm Joytech Healthcare in DBP Plus siriɔs dɔn gɛt FDA 510(k) kliarens ɔnda K261394, we de mek dɛn ebul fɔ kɔmɛshalayz na di US makit.
Fɔ di wɛlbɔdi biznɛs brand ɛn distribyushɔn dɛn we de aktif na di US makit, dis kliarens pas wan rigyuletɔri maylston — na prɛktikal makɛt-ɛntrɛ ɛnabul. Dɛn dɔn rivyu ɛni divays we dɛn dɔn klia as Klas II mɛdikal divays ɛn dɛn dɔn si se i rili ikwal to prɛdikayt dɛn we dɛn dɔn makɛt bay lɔ, wit wan yus we dɛn bin want fɔ yuz we de kɔba di jenɛral pipul dɛn.
Wan Klia Laynap fɔ Siks Nyu Mɔdal dɛn
Di DBP Plus siriɔs de briŋ siks nyu mɔdel dɛn insay Joytech Healthcare in US-klia pɔtfɔlio: DBP-6186 Plɔs, DBP-6286B Plɔs, DBP-61E3 Plɔs, DBP-61E2 Plɔs, DBP-62E3B Plɔs, ɛn DBP-62E2B Plɔs.
Ɛni mɔdel na ful ɔtomɛtik di ɔpa-am blɔd prɛshɔn monita we dɛn bil fɔ mɛzhɔ ɛvride na os. Di siriכs de kכntinyu bak wan pruf rεgεdyushכn laynej — in prɛdisɔs DBP-6186 ɛn DBP-6286B bin klia bay FDA insay 2025 fɔ yuza dɛn wit big an, ɛn di Plus jɛnɛreshɔn de ɛkstɛnd da sem injinɛri pletfɔm de to wan brayt mɔdel rɛnj.
Tu Kɔf Sayz, Wida Yuz Kɔvarej
εvri mכdel na di batch dεn kכnfigyut wit wan pan tu kכf opshכn dεm — wan standad 22–42 cm kכf כ wan εkstend 40–56 cm big an kכf.
Dis dual-cuff aprɔch impɔtant pan kɔmɛshɔnal as mɔ as klinik. I de alaw rital program ɛn institiushɔnal bayer fɔ bil saiz-inkluziv asɔrtimɛnt frɔm wan singl klia prodak famili, so dat big pipul dɛn we dɛn an fɔdɔm ausayd standad kɔf rɛnj nɔ go fos igen fɔ kɔmprɔmis mɛzhɔmɛnt.
Usay Dɛn Monitor ya Fit insay wan US Pɔtfɔlio
Fɔ di wan dɛn we de bay we de evalyu di DBP Plus siriɔs, tri pɔynt dɛn tinap aut:
Di ful siks-mɔdel batch na wan FDA 510(k) kliarens kɔba am, so asɔrtimɛnt planin kin go bifo witout ɛni mɔdal rigyuletɔri gap.
Ɔl tu di standad ɛn big arm kɔf vɛshɔn dɛn de insay di klia skɔp.
Di jenɛral pɔpuleshɔn indikɛshɔn de sɔpɔt bɔku bɔku US distribyushɔn opinion dɛm, inklud rital, i-kɔmrɛs, ɛn ɔda wɛlbɔdi chanɛl dɛm.
Di kliarens rεkɔd insɛf kin bi vεrifik bay patna dεm we dɛn de du di du dilayjens — di K261394 sɔmari na pɔblik aksesbul tru di FDA database.
Dɛn bil am pan wan Established Rɛgyulatɔri Trak Rɛkɔd
Dis raun fɔ kliarens de ad to wan US kɔmplians pɔtfɔlio we de gro na Joytech Healthcare, we dɔn ɔlrɛdi inklud prɛviɔs 510(k) kliarens fɔ blɔd prɛshɔn monita ɛn blɔd glukɔs monitarin sistɛm, nia CE mak ɔnda di EU MDR, ISO 13485 sɛtifiket, ɛn MDSAP kɔmplians.
Fɔ OEM/ODM patna dɛn, da trak rɛkɔd de de shɔt di kɔmplians tɔk: di kwɛstyɔn de shift frɔm if di manifakta kin mit di US rikwaymɛnt dɛn to us mɔdel kɔnfigyushɔn fit di program.
Available fɔ Distribushɔn ɛn OEM/ODM Program dɛn
Joytech Healthcare de aksept naw kwɛstyɔn frɔm US mɛdikal divays distribyushɔn, impɔta, ɛn brand patna dɛn we intres pan di DBP Plus siriɔs — inklud prayvet-lɛbul divɛlɔpmɛnt, kɔstɔm pak, ɛn dɔkyumentri sɔpɔt fɔ makɛt rɛjista.
Bɔt Joytech Ɛlthkɛr
Joytech Healthcare na wan pɔshɔnal manifakta fɔ ɔm wɛlbɔdi biznɛs ɛn mɛdikal monitarin divays, we spɛshal pan blɔd prɛshɔn monita, tɛmɔmɔta, puls ɔksimita, nɛbulayza, brɔst pɔmp ɛn ɔda wɛlbɔdi prɔdak dɛm.
Wi de gi yu OEM/ODM mɛdikal divays sɔlvishɔn fɔ di glob ɔl wɛlbɔdi biznɛs brand, distribyushɔn, ɛn patna dɛn, we de pe atɛnshɔn pan rigyuletɔri kɔmplians, prodak rilaybiliti, ɛn lɔng tɛm kɔpɔreshɔn.
Fɔ aks fɔ evalueshɔn sɛmpul, kliarens dɔkyumentri, ɔ kot fɔ di DBP Plus siriɔs, rich wi tim na sale14@sejoy.com — ɔ browz di ful FDA 510(k) klia blɔd prɛshɔn monita layn ap na wi wɛbsayt.
