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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K191075
Device Name Healy
TimeWaver Production GmbH
Schloss Kranzlin Darritzer Strab 6
Kranzlin,  DE 16818
Applicant Contact Martin Wittmann
Herrington Consulting LLC
2885 Sanford Ave, SW #43083
Grandville,  MI  49418
Correspondent Contact Douglas Herrington
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
Date Received04/23/2019
Decision Date 11/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No