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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 K260396
Device Name KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)
Applicant
Fidelity BioPharma Co.
157 Church St., Suite 1915
New Haven,  CT  06510
Applicant Contact Song Lin
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plz., Shuixi Rd., Huang
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number882.5805
Classification Product Code
OBP  
Date Received02/06/2026
Decision Date 09/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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