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FDA 510(k) Clearance bɛ Ameriki sugu da wuli Joytech DBP Plus tansiyɔn kɔlɔsilikɛlan wɔɔrɔ kama

Views: 0     Author: Site Editor Bɔli waati: 2026-09-04 Bɔyɔrɔ: Yɔrɔ

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Sanfɛla tansiyɔn jateminɛnan otomatiki wɔɔrɔ minnu bɛ bɔ Joytech Healthcare ka DBP Plus seriyali la, olu ye FDA 510(k) ka yamaruya sɔrɔ K261394 kɔnɔ, o min bɛ kɛ sababu ye ka jago kɛ Ameriki sugu la.

Kɛnɛyako taamasiyɛnw ni feerekɛlaw fɛ minnu bɛ baara kɛ Ameriki sugu la, nin yamaruya in ka ca ni sariyasunba ye — a ye sugu doncogo ɲuman ye. Minɛn kelen-kelen minnu jɛlen don, olu lajɛra i n’a fɔ furakɛli minɛn suguya II, wa a sɔrɔla ko u ni kɔrɔfɔ minnu bɛ feere sariya siratigɛ la, olu bɛ bɛn kosɛbɛ, ni baarakɛcogo laɲininen bɛ jamanaden bɛɛ lajɛlen de kan.

Modèle kura wɔɔrɔ ka Lineup jɛlen dɔ

DBP Plus seriyali bɛ na ni fɛn kura wɔɔrɔ ye Joytech Healthcare ka Ameriki ka bolomafara kɔnɔ: DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, ani DBP-62E2B Plus.

Modeli kelen-kelen bɛɛ ye otomatiki ye pewu bolokɔni sanfɛla tansiyɔn jateminɛnan  min jɔra don o don so sumani kama. O seriyali fana bɛ t’a fɛ ni sariyasunba bɔnsɔn sɛgɛsɛgɛlen ye — a ɲɛfɛfɛnw DBP-6186 ni DBP-6286B ye FDA ka san 2025 labɔ  ka ɲɛsin baarakɛlaw ma minnu bolow ka bon, wa Plus bɔnsɔn bɛ o ɛntɛrinɛti yɔrɔ kelen in bonya ka se modeli caman ma.

Cuff Sizes fila, Baarakɛlaw ka coverage ka bon

Modeli bɛɛ min bɛ batch kɔnɔ, o labɛnna ni mansin sugandilen fila dɔ ye — mansin standard min janya ye santimɛtɛrɛ 22–42 ye walima bolokɔniba min janya ye santimɛtɛrɛ 40–56 ye.

Nin fɛɛrɛ fila-fila in nafa ka bon jago siratigɛ la i n’a fɔ kɛnɛyaso ta fan fɛ. A b’a to feerekɛlaw ka porogaramuw ni sigida sannikɛlaw ka se ka fɛn suguya kelenw jɔ minnu bɛ bonya bɛɛ lajɛlen ta ka bɔ fɛn dilannenw denbaya kelen na min jɛlen don, walasa baliku minnu bolow bɛ bin mansin dancɛw kɔkan, olu kana wajibiya tugun ka bɛnkan sumanikɛlanw kɛ.

Nin kɔlɔsilikɛlaw bɛ bɛn yɔrɔ min na Ameriki ka portefeuille dɔ kɔnɔ

Sannikɛlaw minnu bɛ DBP Plus seriyali jateminɛ, fɛn saba bɛ bɔ kɛnɛ kan:

  • Modeli wɔɔrɔ dafalen bɛ dafa ni FDA 510(k) ka yamaruya kelen ye, o la, suguya caman bolodacogo bɛ se ka taa ɲɛ ni misali kelen-kelen bɛɛ ka sariyaw cɛ danfara tɛ.

  • Bolocicogo jɔnjɔn ni bolokɔni belebele fila bɛɛ bɛ sɔrɔ yɔrɔ jɛlen kɔnɔ.

  • Jamanadenw bɛɛ ka jirali bɛ Ameriki ka tilali sira caman dɛmɛ, i n’a fɔ feerelikɛyɔrɔw, ɛntɛrinɛti jago, ani kɛnɛyako sira wɛrɛw.

Cɛsirisɛbɛn yɛrɛ bɛ se ka sɛgɛsɛgɛ jɛɲɔgɔnw fɛ sɛgɛsɛgɛli kɛcogo ɲuman senfɛ — K261394 ka kunnafoni kuncɛlen bɛ se ka sɔrɔ foroba la FDA ka kunnafonidilan fɛ.

A jɔlen bɛ sariyasunba dɔ kan min sigilen don

Nin sɛgɛsɛgɛli in bɛ dɔ fara Ameriki ka sariya labatoli bolodalen kan min bɛ ka bonya Joytech Healthcare la, min kɔnɔ, 510(k) yamaruyaw bɛ sɔrɔ kaban tansiyɔn kɔlɔsilikɛlaw ni joli sukaro kɔlɔsili siraw kama, ka fara CE taamasiyɛn kan EU MDR kɔnɔ, ISO 13485 seereyaw, ani MDSAP sariya labatoli.

OEM/ODM jɛɲɔgɔnw fɛ, o taamasiyɛn bɛ sariya labatoli baro surunya: ɲininkali bɛ wuli ka bɔ ni a dilabaga bɛ se ka Ameriki ka ɲininiw dafa, modɛli labɛncogo min bɛ bɛn porogaramu ma.

A bɛ sɔrɔ Jatebɔ ni OEM/ODM Porogaramuw kama

Joytech Healthcare bɛ ka sɔn ɲininkaliw ma sisan ka bɔ Ameriki furakɛli minɛnw feerelaw fɛ, u donbagaw fɛ, ani u ka fɛn dilannenw jɛɲɔgɔnw fɛ minnu b’u mago don DBP Plus seriyali la — i n’a fɔ mɔgɔ kelen-kelen ka fɛnw dilanni, u ka pakew dilanni, ani sɛbɛnw dɛmɛni suguya sɛbɛnni kama.

Joytech Healthcare ko la

Joytech Healthcare   ye so kɛnɛyako ni furakɛli kɔlɔsili minɛnw dilannikɛla ŋana ye, a ka baara ɲɛsinnen bɛ tansiyɔn jateminɛnanw ma, funteni jateminɛnanw, dusukun tantanni jateminɛnanw, nebulizerw, sinji pɔnpew ani kɛnɛyako fura wɛrɛw.

An bɛ di OEM/ODM furakɛli minɛnw ɲɛnabɔcogo  diɲɛ kɛnɛyako taamasiyɛnw, feerekɛlaw ani jɛɲɔgɔnw ye, minnu sinsinnen bɛ sariyaw labatoli kan, fɛn dilannenw dannaya, ani jɛkafɔ kuntaalajan.

Aw ye ɲɔgɔn sɔrɔ Anw fɛ

Walasa ka jateminɛ kɛcogo misaliw ɲini, ka sɛbɛnw bɔli sɛbɛnw di, walima ka DBP Plus seriyali quotation ɲini, aw bɛ se ka se an ka kulu ma nin yɔrɔ in na sale14@sejoy.com — walima ka FDA 510(k) ka tansiyɔn sɛgɛsɛgɛlikɛlan jɛlenw bɛɛ lajɛ an ka siti kan.

 NO.365, Wuzhou sira kan, Hangzhou, Zhejiang mara la, 311100, Sinuwa jamana na

 No.502, Shunda sira kan, Hangzhou, Zhejiang mara la, 311100, Sinuwa jamana na
 

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