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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 K202337
Device Name Pulsed electromagnetic field wrap
Applicant
Hi-Dow International, Inc.
2555 Metro Blvd.
Maryland Heights,  MO  63043
Applicant Contact Eric Chen
Correspondent
Hi-Dow International, Inc.
2555 Metro Blvd.
Maryland Heights,  MO  63043
Correspondent Contact Eric Chen
Regulation Number890.5290
Classification Product Code
ILX  
Subsequent Product Code
IRT  
Date Received08/17/2020
Decision Date 12/15/2020
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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