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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 K251653
Device Name SPRY TMS Therapy System (0550)
Applicant
Soterix Medical, Inc.
1480 Us Highway 9n, Suite 204
Woodbridge,  NJ  07095
Applicant Contact Abhishek Datta
Correspondent
Soterix Medical, Inc.
1480 Us Highway 9n, Suite 204
Woodbridge,  NJ  07095
Correspondent Contact Abhishek Datta
Regulation Number882.5805
Classification Product Code
OBP  
Date Received05/29/2025
Decision Date 02/20/2026
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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