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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name External Upper Limb Tremor Stimulator
510(k) Number K203288
Device Name Cala Trio
Applicant
Cala Health, Inc.
875 Mahler Rd., Suite 168
Burlingame,  CA  94010
Applicant Contact Amanda Johnston
Correspondent
Cala Health, Inc.
875 Mahler Rd., Suite 168
Burlingame,  CA  94010
Correspondent Contact Danielle McDonnell Boyd
Regulation Number882.5897
Classification Product Code
QBC  
Date Received11/09/2020
Decision Date 10/05/2021
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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