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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 K253587
Device Name Cala kIQ Plus
Applicant
Cala Health, Inc.
1800 Gateway Dr., Suite 120
San Mateo,  CA  94404
Applicant Contact Khushboo Surendran
Correspondent
Cala Health, Inc.
1800 Gateway Dr., Suite 120
San Mateo,  CA  94404
Correspondent Contact Khushboo Surendran
Regulation Number882.5897
Classification Product Code
QBC  
Date Received11/17/2025
Decision Date 03/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Clinical Trials NCT03597100
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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