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eXciteOSA

801600001 · Signifier Medical Technologies Limited

eXciteOSA mouthpiece (REF 801600001); single patient use, replaced 90 days after first use. Supplied in the eXciteOSA Starter Kits (DI 05060627480048 and 05060627480000) and sold separately as a replacement (mouthpiece-only pack REF 16000, DI 05060627480017). eXciteOSA is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce snoring and mild obstructive sleep apnea (AHI<15) for patients that are 18 years or older. Rx only.

Details

Device typeSleep-disordered breathing tongue electrical stimulator: An electronic device intended to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea), by improving tongue muscular tone achieved by applying a program of electrical stimulation to the tongue during waking hours. It consists of an electrode with various contact points designed to fit around the tongue, and a remote control unit which may be software on a mobile device. It is normally available [non-prescription] over-the-counter (OTC) as a single-patient, reusable device.

FDA categoryNeuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

Device ID05060627480017

AvailabilityPrescription

MRI safetyLabeling does not contain MRI Safety Information

Contact

Phone844-645-3672

Emailsupport@signifiermedical.com

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