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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 Other Than Applying Therapeutic Deep Heat
510(k) Number K091791
Device Name PROVANT SYSTEM, MODEL 4201
Applicant
Regenesis Biomedical, Inc.
1435 N. Hayden Rd.
Scottsdale,  AZ  85257
Applicant Contact RICHARD ISENBERG
Correspondent
Regenesis Biomedical, Inc.
1435 N. Hayden Rd.
Scottsdale,  AZ  85257
Correspondent Contact RICHARD ISENBERG
Regulation Number890.5290
Classification Product Code
ILX  
Date Received06/17/2009
Decision Date 04/07/2010
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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