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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stationary ultrasonic diathermy device for use in applying therapeutic deep heat
510(k) Number K221210
Device Name PainShield MD PLUS
Applicant
NanoVibronix, Inc.
525 Executive Blvd.
Elmsford,  NY  10523
Applicant Contact Hrishikesh Gadagkar
Correspondent
NanoVibronix, Inc.
525 Executive Blvd.
Elmsford,  NY  10523
Correspondent Contact Hrishikesh Gadagkar
Regulation Number890.5300
Classification Product Code
PFW  
Date Received04/27/2022
Decision Date 11/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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