Ihe nlebanya ọbara mgbali elu nke elu aka isii sitere na usoro Joytech Healthcare's DBP Plus ka enyerela FDA 510(k) ikike n'okpuru K261394, na-eme ka azụmaahịa na ahịa US.
Maka ụdị nlekọta ahụike na ndị nkesa na-arụsi ọrụ ike na ahịa US, nchapụta a karịrị usoro iwu iwu - ọ bụ ihe na-enye aka ịbanye ahịa. Atụlela ngwaọrụ ọ bụla ekpochapụrụ dị ka ngwaọrụ ahụike klaasị II wee hụ na ọ dabara nke ọma na amụma ahịa iwu kwadoro, yana ebumnuche kpuchiri ndị mmadụ niile.
Ụdịdị ọhụrụ isii ekpochapụrụ
Usoro DBP Plus na-eweta ụdị ọhụrụ isii n'ime Pọtụfoliyo kpochapụrụ US nke Joytech Healthcare: DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, na DBP-62E2B Plus.
Ụdị ọ bụla bụ akpaka zuru oke Ihe nleba anya ọbara mgbali elu nke ogwe aka arụrụ maka nha ụlọ kwa ụbọchị. Usoro a na-agakwa n'ihu n'usoro usoro iwu pụtara - Ndị bu ya ụzọ DBP-6186 na DBP-6286B bụ ndị FDA kpochapụrụ na 2025 maka ndị ọrụ nwere ogwe aka buru ibu, na ọgbọ Plus na-agbatị otu usoro injinịa ahụ gaa n'ụdị ụdị sara mbara.
Nha cuff abụọ, mkpuchi onye ọrụ sara mbara
A na-ahazi ụdị ọ bụla dị na batch na otu n'ime nhọrọ cuff abụọ - ọkọlọtọ 22-42 cm cuff ma ọ bụ agbatị 40-56 cm nnukwu ogwe aka.
Uzo abuo-cuff a na-abara ahia dika ulo ogwu. Ọ na-enye ohere ka mmemme mkpọsa na ndị na-azụ ahịa ụlọ ọrụ wuo ụdịdị nha nha nke sitere na otu ezinụlọ ngwaahịa kpochapụrụ, nke mere na ndị okenye nke ogwe aka ha daa n'èzí ọkọlọtọ cuff agaghịzi amanye ime nha.
Ebe nlekota ndị a dabara na Pọtụfoliyo US
Maka ndị na-azụ ahịa na-enyocha usoro DBP Plus, isi ihe atọ pụtara:
Otu akwụkwọ ikike FDA 510 (k) kpuchiri batch isii zuru oke, yabụ atụmatụ nhazi nwere ike ịga n'ihu na-enweghị oghere nhazi nke ụdị ọ bụla.
Abụọ ọkọlọtọ na nnukwu ogwe aka cuff dị n'ime oke ekpochapụrụ.
Ngosipụta ọnụ ọgụgụ mmadụ n'ozuzu na-akwado ohere nkesa US sara mbara, gụnyere mkpọsa ahịa, e-azụmahịa, na ọwa ahụike ndị ọzọ.
Ndị mmekọ nwere ike nyochaa ndekọ mkpochapụ ahụ n'onwe ya n'oge nyocha nke ọma - nchịkọta K261394 na-enweta n'ihu ọha site na nchekwa data FDA.
Ewubere ya na Ndekọ egwu Ewubere
Mkpesa nke a na-agbakwụnye na Pọtụfoliyo nrubeisi US na-eto eto na Joytech Healthcare, nke gụnyelarị tupu 510 (k) mkpochapụ maka ndị na-ahụ maka ọbara mgbali elu na sistemu glucose ọbara, yana akara CE n'okpuru EU MDR, asambodo ISO 13485, yana nnabata MDSAP.
Maka ndị mmekọ OEM/ODM, ndekọ egwu ahụ na-ebelata mkparịta ụka nnabata: ajụjụ na-agbanwe site na ma onye nrụpụta nwere ike iru ihe US chọrọ nke nhazi ụdị dabara na mmemme ahụ.
Dị maka nkesa yana mmemme OEM/ODM
Joytech Healthcare na-anabata ajụjụ ugbu a sitere n'aka ndị na-ekesa ngwaọrụ ahụike US, ndị mbubata, na ndị mmekọ ika nwere mmasị na usoro DBP Plus - gụnyere mmepe akara aha onwe, nkwakọ ngwaahịa omenala, na nkwado akwụkwọ maka ndebanye aha ahịa.
Banyere Joytech Healthcare
Joytech Healthcare bụ ọkachamara na-emepụta ahụike ụlọ na ngwaọrụ nlekota ahụike, ọkachamara na nlekota ọbara mgbali elu, thermometers, pulse oximeters, nebulizers, nfuli ara na ngwaahịa nlekọta ahụike ndị ọzọ.
Anyị na-enye Ihe ngwọta ngwaọrụ ahụike OEM/ODM maka ụdị ahụike ahụike ụwa, ndị nkesa, na ndị mmekọ, na-elekwasị anya na nrube isi n'usoro iwu, ntụkwasị obi ngwaahịa, yana imekọ ihe ọnụ ogologo oge.
Iji rịọ nlele nlele, akwụkwọ ikike, ma ọ bụ nhota maka usoro DBP Plus, rute ndị otu anyị na sale14@sejoy.com - ma ọ bụ chọgharịa FDA 510 (k) zuru ezu usoro nyocha ọbara mgbali elu na webụsaịtị anyị.
