FDA Qhia Owlet kom tsis txhob muag Nws Cov Ntsiab Lus Me Nyuam Ntsej Muag

Owlet tau raug yuam kom tsis txhob muag nws qhov nrov Smart Sock rau kev saib xyuas tus menyuam lub plawv dhia, qib oxygen, thiab kev pw tsaug zog.

As DeseretNews qhia, US Food & Drug Administration (FDA) xa Owlet tsab ntawv ceeb toom Lub hli tas los hais tias lub tuam txhab tau "kev lag luam Owlet Smart Socks hauv Tebchaws Meskas yam tsis muaj kev lag luam muag lossis kev pom zoo, ua txhaum cai ntawm Tsoom Fwv Teb Chaws Khoom Noj, Tshuaj, thiab Tshuaj pleev ib ce (Txoj Cai)."

Yog vim li cas rau qhov kev ua txhaum cai yog vim lub Smart Sock raug cais raws li cov cuab yeej kho mob vim qhov tseeb tias lawv "yog siv rau hauv kev kuaj mob lossis lwm yam mob lossis hauv kev kho, txo qis, kho, lossis tiv thaiv kab mob, lossis cuam ​​tshuam rau cov qauv lossis kev ua haujlwm ntawm lub cev. "

FDA tau thov Owlet kom tsis txhob muag cov cuab yeej hauv Asmeskas, thiab tam sim no Owlet tau ua raws li qhov kev thov ntawd. Hauv ib FDA Teb cov lus teb Owlet hais tias:

"Raws li qhov tshwm sim ntawm tsab ntawv thiab pom ntawm peb cov phiaj xwm xa daim ntawv thov khoom siv rau FDA, peb yuav tsis muag Smart Sock ntxiv lawm. Peb npaj yuav muab kev tshuaj xyuas kev pw tsaug zog tshiab, uas peb ntseeg tias yuav muaj soon. Peb kuj npaj yuav txuas ntxiv txhawb peb cov neeg siv khoom tam sim no. Tsis tau muaj kev hloov pauv rau koj cov khoom ua haujlwm lossis kev thov los ntawm FDA los pauv lossis xa koj cov khoom rov qab rau lub sijhawm no. Peb yuav ceeb toom rau cov neeg siv khoom ntawm txhua qhov hloov tshiab rau Smart Sock cov khoom lag luam uas twb tau xa tawm lawm. Qhov kev txiav txim no tshwj xeeb rau Asmeskas nkaus xwb thiab tsis muaj lwm lub tebchaws lossis cheeb tsam cuam tshuam los ntawm qhov no. "

Owlet tseem tau taw qhia tias tsab ntawv "tsis tau txheeb xyuas qhov kev txhawj xeeb txog kev nyab xeeb ntawm Smart Sock," uas yuav zoo siab tos txais xov xwm rau ntau tshaj li ib lab tus niam txiv uas tau yuav ib qho.

Nws muaj kev nyab xeeb los txuas ntxiv siv Smart Sock, tab sis hauv Asmeskas lawv tsis muaj muag lawm. Cov niam txiv yuav raug tso tseg tos rau kev tshuaj xyuas kev pw tsaug zog tshiab Owlet tab tom ua haujlwm, tab sis kuj rau FDA pom zoo nws raug muag thiab muag.