Wɔama FDA 510(k) kwan wɔ K261394 ase, na ɛma wotumi de di gua wɔ U.S. gua so.
Wɔ akwahosan ho ahyɛnsode ne wɔn a wɔkyekyɛ nneɛma a wɔyɛ nnam wɔ U.S. gua so no, saa tumi krataa yi boro mmara kwan so ade titiriw — ɛyɛ ade a mfaso wɔ so a ɛma wotumi kɔ gua so. Wɔasan ahwɛ mfiri biara a wɔayi afi hɔ mu sɛ Class II aduruyɛ mfiri na wɔahu sɛ ɛne nsɛmfua a wɔde di dwuma wɔ mmara kwan so no yɛ pɛ kɛse, na sɛnea wɔahyɛ da de adi dwuma no kata ɔmanfo nyinaa so.
A Cleared Lineup of Nnwom Foforo Nsia
DBP Plus series no de mfonini foforo asia ba Joytech Healthcare portfolio a U.S. agye atom no mu: DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, ne DBP-62E2B Plus.
Model biara yɛ automatic koraa abasa atifi mogya mmoroso kyerɛwtohɔ a wɔasi sɛ wɔde susuw fie da biara da. Ntoatoaso no nso kɔ so yɛ mmara kwan so abusua a wɔada no adi — . nea edii n’anim DBP-6186 ne DBP-6286B no, FDA yii no fii hɔ wɔ afe 2025 mu maa wɔn a wɔde di dwuma a wɔwɔ nsa akɛse, na Plus awo ntoatoaso no trɛw saa mfiridwuma kwan koro no ara mu kɔ mfonini ahorow a ɛtrɛw mu.
Cuff Sizes Abien, Ɔdefo a Wɔde Di Dwuma a Ɛtrɛw
Wɔahyehyɛ model biara a ɛwɔ batch no mu no ne cuff abien a wɔpaw no mu biako — standard 22–42 cm cuff anaasɛ 40–56 cm kɛse abasa cuff a wɔatrɛw mu.
Saa kwan a wɔfa so de nsa abien na ɛyɛ adwuma yi ho hia wɔ aguadi mu te sɛ nea ɛho hia wɔ ayaresabea no. Ɛma aguadidan nhyehyɛe ahorow ne ahyehyɛde ahorow a wɔtɔ nneɛma no tumi kyekye nneɛma ahorow a ne kɛse ka ho fi nneɛma abusua biako a wɔaprapra mu mu, sɛnea ɛbɛyɛ a wɔrenhyɛ mpanyimfo a wɔn nsa hwe ase wɔ nsateaa a wɔahyɛ da ayɛ no akyi bio sɛ wɔnkɔ susuw nneɛma mu.
Baabi a Saa Monitors Yi Fata wɔ U.S. Portfolio mu
Wɔ adetɔfo a wɔresusuw DBP Plus series no ho no, nsɛntitiriw abiɛsa da nsow:
FDA 510(k) clearance baako na ɛkata asia-model batch a edi mũ no so, enti assortment nhyehyɛe betumi akɔ so a model biara mmara mu nsonsonoe biara nni mu.
Standard ne large arm cuff versions nyinaa wɔ hɔ wɔ cleared scope no mu.
Nnipa dodow nyinaa ho nkyerɛkyerɛmu no foa U.S. nkyekyɛmu hokwan ahorow pii so, a aguadidan, e-commerce, ne akwahosan ho akwan afoforo ka ho.
Clerance kyerɛwtohɔ no ankasa betumi ayɛ nea ahokafo betumi agye atom wɔ nhwehwɛmu a ɛfata mu — K261394 nsɛm a wɔaboaboa ano no yɛ nea ɔmanfo betumi anya denam FDA database no so.
Wɔde sii Mmarahyɛ Nsɛm a Wɔahyehyɛ so
Saa kwan yi a wɔde ma no de ka U.S. mmara sodi ho nhyehyɛe a ɛrenya nkɔanim wɔ Joytech Healthcare, a nea ɛka ho dedaw a 510(k) a wɔadi kan agye atom ama mogya mmoroso a wɔhwɛ ne mogya mu glucose nhyehyɛe nhyehyɛe ahorow, ka CE agyiraehyɛde a ɛwɔ EU MDR, ISO 13485 adansedi, ne MDSAP a wodi so no ho.
Wɔ OEM/ODM ahokafo fam no, saa track record no ma nkɔmmɔbɔ a ɛfa mmara sodi ho no yɛ tiaa: asɛmmisa no dan fi sɛ ebia nea ɔyɛe no betumi adi U.S. ahwehwɛde ahorow ho dwuma wɔ model nhyehyɛe a ɛfata dwumadi no so anaa.
Ɛwɔ hɔ ma Nkyekyɛmu ne OEM/ODM Nhyehyɛe ahorow
Joytech Healthcare mprempren regye nsɛmmisa a efi U.S. nnuruyɛ mfiri kyekyɛfo, wɔn a wɔde nneɛma ba amannɔne, ne wɔn a wɔyɛ brand ahokafo a wɔn ani gye DBP Plus series no ho — a private-label nkɔso, amanne kwan so nneɛma a wɔde kyekyere nneɛma, ne nkrataa a wɔde boa ma wɔkyerɛw wɔn din wɔ gua so ka ho.
Joytech Akwahosan Ho Nsɛm
Joytech Healthcare yɛ adwumayɛfoɔ a wɔyɛ ofie akwahosan ne nnuruyɛ ho mfiri a wɔde hwɛ nneɛma so, a wɔn ho akokwaw wɔ mogya mmorosoɔ a wɔde hwɛ, thermometers, pulse oximeters, nebulizers, nufu pɔmpɛ ne akwahosan ho nneɛma foforɔ mu.
Yɛde ma OEM/ODM aduruyɛ mfiri ano aduru ma wiase nyinaa akwahosan ho ahyɛnsode, wɔn a wɔkyekyɛ, ne ahokafo, a wɔde wɔn adwene si mmara a wodi so, nneɛma a wotumi de ho to so, ne bere tenten biakoyɛ so.
Sɛ wopɛ sɛ wobisa nhwehwɛmu nhwɛsoɔ, clearance nkrataa, anaa quotation ma DBP Plus series no a, kɔ yɛn kuo no nkyɛn wɔ sale14@sejoy.com — anaa hwehwɛ FDA 510(k) cleared mogya mmoroso monitor lineup nyinaa wɔ yɛn wɛbsaet no so.
