Joytech Healthcare-a DBP Plus series aṭanga upper-arm automatic blood pressure monitor paruk chu K261394 hnuaiah FDA 510(k) clearance pek a ni a, hei hian US market-ah sumdawnna atana hman theih a ni.
US market-a thawk healthcare brand leh distributor-te tan chuan he clearance hi regulatory milestone aiin a tam zawk — practical market-entry enabler a ni. Cleared device tinte chu Class II medical device anga enfiah a ni a, dan anga market-a hralh chhuah predicate nen a inang tlang hle tih hmuhchhuah a ni a, hman tumna chuan mipui zawng zawng a huam vek a ni.
Model thar paruk awmna Lineup Cleared
DBP Plus series hian Joytech Healthcare-in US-a a clear portfolio-ah model thar paruk a rawn keng tel a, chungte chu DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, leh DBP-62E2B Plus te an ni.
Model tin hi fully automatic a ni upper-arm blood pressure monitor . nitin in lama tehna atana siam He series hian regulatory lineage finfiah tawh pawh a chhunzawm zel bawk — a hmaa DBP-6186 leh DBP-6286B te chu FDA chuan kum 2025 khan arm lian zawk nei tan a clear a, Plus generation hian chu engineering platform ang chiah chu model range zau zawkah a tizau a ni.
Cuff Size pahnih, User Coverage zau zawk
Batch chhunga model zawng zawng hi cuff option pahnih zinga pakhat — standard 22–42 cm cuff emaw extended 40–56 cm large arm cuff emaw hmanga configure a ni.
He dual-cuff approach hi sumdawnna lamah pawh a pawimawh ang bawkin clinical lamah pawh a pawimawh hle. Retail program leh institutional buyer-te chu cleared product family pakhat aṭanga size-inclusive assortment siam theihna a siamsak a, chutiang chuan puitling, an kut chu standard cuff range pawna tlate chu compromise measurement-ah an inhnukdawk tawh lo.
Heng Monitor te hi US Portfolio-a an in fitna hmun
DBP Plus series evaluate-tu buyers tan chuan point pathum a langsar hle a, chungte chu:
Model paruk awmna batch kimchang hi FDA 510(k) clearance pakhatin a huam a, chuvangin assortment planning hi model khata regulatory gap awm lovin kalpui theih a ni.
Standard leh large arm cuff version pahnih hi cleared scope chhungah a awm vek a ni.
General population indication hian US distribution opportunity hrang hrang a thlawp a, retail, e-commerce, leh healthcare channel dangte pawh a thlawp a ni.
Clearance record ngei pawh hi due diligence neih chhungin partner-te chuan an finfiah thei a ni — K261394 summary hi FDA database kaltlangin mipui hriat theih a ni.
Regulatory Track Record din tawh chunga sak a ni
He clearance round hian Joytech Healthcare-a US compliance portfolio pung zel chu a belhchhah a, hei hian blood pressure monitor leh blood glucose monitoring system-te tana 510(k) clearance hmasa ber a huam tawh a, EU MDR hnuaia CE marking, ISO 13485 certification, leh MDSAP compliance te nen a huam tel bawk.
OEM/ODM partner-te tan chuan chu track record chuan compliance inbiakna chu a ti tawi a: zawhna chu siamtuin US mamawh a tlin theih leh theih loh aangin a inthlak a, eng model configuration nge program nena inmil tih aangin.
Distribution leh OEM/ODM Programme atan pawh a awm
Joytech Healthcare hian tunah hian US medical device distributor, importer, leh DBP Plus series ngaihven brand partner-te zawhna a pawm mek a — private-label development, custom packaging, leh market registration atana documentation support te pawh a tel.
Joytech Healthcare chungchang
Joytech Healthcare hi in lama healthcare leh medical monitoring devices siamtu professional a ni a, thisen sang monitor, thermometer, pulse oximeter, nebulizer, breast pump leh healthcare product dangte siamna lama tui tak a ni.
Kan pe a ni Khawvel pum huapa healthcare brand, distributor, leh partner-te tana OEM/ODM medical device solutions , regulatory compliance, product rintlakna, leh hun rei tak chhunga thawhhona lam ngaihtuah a ni.
Evaluation sample, clearance documentation, emaw DBP Plus series atana quotation dil duh tan kan team hi sale14@sejoy.com — emaw, FDA 510(k) cleared blood pressure monitor lineup kimchang chu kan website-ah en theih a ni.
