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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transcranial Magnetic Stimulator
510(k) Number K250689
Device Name CloudTMS Edge
Applicant
Teleemg, LLC
167 Poinsettia Pl.
Los Angeles,  CA  90036
Applicant Contact Jabre Joe
Correspondent
Makromed, Inc.
88 Stiles Rd.
Salem,  NH  03079
Correspondent Contact Ashar Barry
Regulation Number882.5805
Classification Product Code
OBP  
Date Received03/06/2025
Decision Date 09/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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