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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 K260050
Device Name WRAP System
Applicant
Huneo, LLC
35000 Chardon Rd.
Willoughby Hills,  OH  44094
Applicant Contact Philip Ryder
Correspondent
Huneo, LLC
35000 Chardon Rd.
Willoughby Hills,  OH  44094
Correspondent Contact Philip Ryder
Regulation Number868.2375
Classification Product Code
MNR  
Subsequent Product Codes
OLV   OLZ  
Date Received01/07/2026
Decision Date 07/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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