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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K210284
Device Name ManaSport
Applicant
Manamed, Inc.
5240 W. Charleston Blvd.
Las Vegas,  NV  89146
Applicant Contact Trevor Theriot
Correspondent
Jkh USA, LLC
14271 Jeffrey Rd.
#246
Irvine,  CA  92620
Correspondent Contact Bill Quanqin Dai
Regulation Number890.5300
Classification Product Code
IMI  
Subsequent Product Code
PFW  
Date Received02/02/2021
Decision Date 04/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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