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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
510(k) Number K223620
Device Name Reprieve by RegenesisTM
Applicant
Regenesis Biomedical, Inc.
5301 N Pima Rd., Suite 150
Scottsdale,  AZ  85250
Applicant Contact Randy Chavez
Correspondent
Regenesis Biomedical, Inc.
5301 N Pima Rd., Suite 150
Scottsdale,  AZ  85250
Correspondent Contact Randy Chavez
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received12/05/2022
Decision Date 05/24/2023
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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