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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K252396
Device Name Cryo Sport 2.0 (AVA 501)
Applicant
Avanutri Equipamentos DE Saúde
Rua Santo Antônio, Nº 2262
Tres Rios,  BR 25820-185
Applicant Contact Daiana Vieira
Correspondent
Bhp Consulting, LLC
Rua Santo Antônio, Nº 2262
Tres Rios,  BR 25820-185
Correspondent Contact Bruno Milhoci
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Code
ILO  
Date Received07/31/2025
Decision Date 05/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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