Taiwan FDA registration 18d574dcf68b46d04a85e23824511bd9

"Oboma" sleep position device

TW: “俄博瑪”睡眠姿勢裝置
Taiwan flagTaiwan·Risk Class 2·Advanced Brain Monitoring, Inc.·Registered May 31, 2020 – May 31, 2025Expired
Registration details
Analysis ID
18d574dcf68b46d04a85e23824511bd9
Customs Code
DHA05603366308
Company information
Manufacturer Country
United States
Authorized Representative
BROJAW INC.
Product details
Intended Use
This device is used in adult patients with postural sleep apnea and patients with non-supine apnea index (Apnea–Hypopnea Index) less than 20, to give the neck vibration stimulation during the supine sleeping position to maintain the non-supine sleeping position, so as to reduce the occurrence of apnea and reduce or slow down snoring. The device provides a record of sleeping position, rollover and snoring sounds, and evaluates sleep quality and snoring by changes in sleeping position.
Product Type (Level 1)
F Dentistry
Product Type (Level 2)
F.5570 Intraoral devices for the treatment of snoring or obstructive sleep apnea
Import Information
import
Dates and status
Registration Date
May 31, 2020
Expiry Date
May 31, 2025
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About this record

Access comprehensive regulatory information for "Oboma" sleep position device in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 18d574dcf68b46d04a85e23824511bd9 and manufactured by Advanced Brain Monitoring, Inc.. The authorized representative in Taiwan is BROJAW INC..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Advanced Brain Monitoring, Inc., and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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