Ebyuma mukaaga ebikebera puleesa mu ngalo ebya waggulu okuva mu kkampuni ya Joytech Healthcare eya DBP Plus series biweereddwa olukusa okuva mu FDA 510(k) wansi wa K261394, ekisobozesezza okutunda mu katale ka Amerika.
Ku bika by’ebyobulamu n’abasaasaanya abakola mu katale ka Amerika, okukkiriza kuno kusingako ku nsonga y’okulungamya — kisobozesa okuyingira akatale mu nkola. Buli kyuma ekirongooseddwa kyekenneenyeddwa ng’ekyuma eky’obujjanjabi ekya Class II era ne kizuulibwa nga kyenkana nnyo n’ebigambo ebimanyiddwa mu katale mu mateeka, ng’enkozesa egenderere ekwata ku bantu bonna.
A Cleared Lineup ya Models Empya mukaaga
DBP Plus series ereeta ebika ebipya mukaaga mu kifo kya Joytech Healthcare ekyakkirizibwa Amerika: DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, ne DBP-62E2B Plus.
Buli mmotoka ya otomatiki mu bujjuvu ekipima puleesa y’omukono ogwa waggulu ekyazimbibwa okupima awaka buli lunaku. Omusomo guno era gugenda mu maaso n’olunyiriri lw’amateeka olukakasibwa — ezaasooka DBP-6186 ne DBP-6286B zalongoosebwa FDA mu 2025 eri abakozesa abalina emikono eminene, era omulembe gwa Plus gugaziya omukutu ogwo gwe gumu ogwa yinginiya okutuuka ku mutindo omugazi.
Sayizi za Cuff bbiri, Okubikka kw’abakozesa okugazi
Buli model mu batch etegekebwa n’ekimu ku bibiri cuff options — standard 22–42 cm cuff oba extended 40–56 cm large arm cuff.
Enkola eno ey’okusiba emiguwa ebiri ekwata ku by’obusuubuzi nga bwe kiri mu bujjanjabi. Kisobozesa pulogulaamu z’ebyamaguzi n’abaguzi b’ebitongole okuzimba ebika ebizingiramu obunene okuva mu famire emu ey’ebintu ebirongooseddwa, olwo abantu abakulu emikono gyabwe gye gigwa ebweru w’ebipimo by’enkoba ebya mutindo ne batakyawalirizibwa kupima kukkaanya.
Monitors Zino Wezituukira mu Portfolio ya Amerika
Ku baguzi abeekenneenya omuzannyo gwa DBP Plus series, ensonga ssatu ze zisinga okulabika:
Ekibinja ekijjuvu eky’ebika mukaaga kibikkiddwako olukusa lumu olwa FDA 510(k), kale enteekateeka y’okusengeka eby’enjawulo esobola okugenda mu maaso awatali bbanga mu mateeka ga buli mulembe.
Enkyusa zombi eza standard ne large arm cuff zisangibwa mu cleared scope.
Ekiraga omuwendo gw’abantu bonna kiwagira emikisa mingi egy’okusaasaanya mu Amerika, omuli eby’obusuubuzi, eby’obusuubuzi ku yintaneeti, n’emikutu emirala egy’ebyobulamu.
Likodi y’okugogola yennyini esobola okukakasibwa abakolagana mu kiseera ky’okunoonyereza okutuufu — mu bufunze K261394 efunibwa mu lujjudde okuyita mu database ya FDA.
Yazimbibwa ku Regulatory Track Record Eteereddwawo
Laawundi eno ey’okukkiriza omusaayi eyongera ku kitongole ky’okugoberera amateeka mu Amerika ekigenda kyeyongera mu Joytech Healthcare, nga muno mulimu edda okukkiriza okwasooka okwa 510(k) eri abalondoola puleesa n’enkola z’okulondoola glucose mu musaayi, wamu n’okussaako obubonero bwa CE wansi wa EU MDR, satifikeeti ya ISO 13485, n’okugoberera MDSAP.
Ku bakolagana ne OEM/ODM, ebyafaayo ebyo bifunza emboozi y’okugoberera: ekibuuzo kikyuka okuva ku oba omukozi asobola okutuukiriza ebisaanyizo bya Amerika okutuuka ku nsengeka y’ekyokulabirako ki ekwatagana ne pulogulaamu.
Esangibwa ku Pulogulaamu z’Okusaasaanya ne OEM/ODM
Joytech Healthcare mu kiseera kino ekkiriza okubuuza okuva mu bagaba ebyuma by’obujjanjabi mu Amerika, abayingiza ebintu mu ggwanga, n’abakolagana nabo mu kika ky’ebintu abafaayo ku DBP Plus series — omuli okukulaakulanya ebyuma eby’obwannannyini, okupakinga ku mutindo, n’okuwagira ebiwandiiko okuwandiisa akatale.
Ebikwata ku Joytech Healthcare
Joytech Healthcare kkampuni ya kikugu mu kukola ebyuma ebilondoola ebyobulamu by’awaka n’eby’obujjanjabi, ng’ekuguse mu byuma ebipima puleesa, ebipima ebbugumu, ebipima pulse oximeters, nebulizers, ppampu z’amabeere n’ebintu ebirala eby’ebyobulamu.
Tuwaayo OEM/ODM medical device solutions for global healthcare brands, distributors, and partners, nga essira liteekeddwa ku kugoberera amateeka, okwesigamizibwa kw’ebintu, n’okukolagana okw’ekiseera ekiwanvu.
Okusaba sampuli z’okwekenneenya, ebiwandiiko by’okugogola, oba quotation ya DBP Plus series, tuukirira ttiimu yaffe ku... sale14@sejoy.com — oba genda mu bujjuvu FDA 510(k) cleared blood pressure monitor lineup ku mukutu gwaffe.
