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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K260136
Device Name Forza
Applicant
True Function Laboratory, Inc.
7851 University Ave.
Suite 103
La Mesa,  CA  91942
Applicant Contact Frank Madrigal
Correspondent
MRC Global, LLC
9160 Hwy. 64, Suite 12
P.O. Box 330
Lakeland,  TN  38002
Correspondent Contact Dawn Norman
Regulation Number872.5570
Classification Product Code
LRK  
Date Received01/16/2026
Decision Date 10/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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