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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 K190251
Device Name RecoveryRx
Applicant
BioElectronics Corporation
4539 Metropolitan Ct
Federick,  MD  21704
Applicant Contact Sree N Koneru
Correspondent
BioElectronics Corporation
4539 Metropolitan Ct
Federick,  MD  21704
Correspondent Contact Sree N Koneru
Regulation Number890.5290
Classification Product Code
ILX  
Date Received02/07/2019
Decision Date 06/28/2019
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
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