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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K212832
Device Name TimeWaver Frequency
Applicant
Timewaver Production GmbH
Schloss Kraenzlin, Darritzer Strass 6
Kraenzlin,  DE 16818
Applicant Contact Babak Jafarian
Correspondent
Herrington Consulting, LLC
2885 Sanford Ave., Sw#43083
Grandville,  MI  49418
Correspondent Contact Douglas Herrington
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
GZJ  
Date Received09/07/2021
Decision Date 12/14/2021
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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