510(k) K240328
K240328 is an FDA 510(k) premarket notification submitted by Signifier Medical Technologies, Ltd. for the device "eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)". The FDA issued a decision of Substantially Equivalent on May 16, 2024. The device falls under product code QNO (Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea), a Class II device regulated under 21 CFR 872.5575. Signifier Medical Technologies, Ltd. has at least 2 other 510(k) clearances on record.
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.