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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 K222237
Device Name Cala kIQ
Applicant
Cala Health, Inc.
1800 Gateway Dr, Suite 300
San Mateo,  CA  94404
Applicant Contact Danielle McDonnell Boyd
Correspondent
Cala Health, Inc.
1800 Gateway Dr, Suite 300
San Mateo,  CA  94404
Correspondent Contact Danielle McDonnell Boyd
Regulation Number882.5897
Classification Product Code
QBC  
Date Received07/26/2022
Decision Date 11/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT05012579
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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