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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K253148
Device Name RX-1 Sleep
Applicant
Vivaquant, Inc. Dba Rhythm Express
1265 Grey Fox Rd., Suite 400
Arden Hills,  MN  55112
Applicant Contact Brian Brockway
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolis,  MN  55402
Correspondent Contact Kathy Herzog
Regulation Number868.2375
Classification Product Code
MNR  
Date Received09/25/2025
Decision Date 06/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT06907888
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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