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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 K242259
Device Name Cala kIQ
Applicant
Cala Health, Inc.
1800 Gateway Dr., Suite 120
San Mateo,  CA  94404
Applicant Contact Alexander Kent
Correspondent
Gardner Law Pllc
423 Main St.
Stillwater,  MN  55082
Correspondent Contact Amanda Johnston
Regulation Number882.5897
Classification Product Code
QBC  
Date Received07/31/2024
Decision Date 11/22/2024
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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