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510(k) K240328

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) by Signifier Medical Technologies, Ltd. — Product Code QNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2024
Date Received
February 5, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
Device Class
Class II
Regulation Number
872.5575
Review Panel
DE
Submission Type

A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea.

Other clearances by Signifier Medical Technologies, Ltd.

  • K223446 — eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) (January 18, 2023)
  • DEN200018 — eXciteOSA with remote and eXciteOSA without remote (February 5, 2021)

Other clearances for product code QNO

  • K223446 — eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) (January 18, 2023)
  • DEN200018 — eXciteOSA with remote and eXciteOSA without remote (February 5, 2021)