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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K253939
Device Name DeltaWave Nasal Pillow System
Applicant
RemSleep Holdings, Inc.
3222 Hwy. 84 Suite 101
Blackshear,  GA  31516
Applicant Contact Tom Wood
Correspondent
ProMedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Anne Dryden Siegal
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/09/2025
Decision Date 01/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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