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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 K220625
Device Name ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
Applicant
Remed Co., Ltd.
#301-#303 Migun Techno World Ii, 187, Techno 2-Ro
Yuseong-Gu
Daejeon,  KR 34025
Applicant Contact Yuna Cho
Correspondent
Allura Medical Solutions, Inc.
5485 Rathdrum Way
Antioch,  CA  94531
Correspondent Contact Soojung Moon
Regulation Number882.5805
Classification Product Code
OBP  
Date Received03/03/2022
Decision Date 04/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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