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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name external upper limb tremor stimulator
De Novo Number DEN170028
Device Name Cala ONE
Cala Health, Inc.
875 mahler road.
suite 168
burlingame,  CA  94010
Contact scott a. wilson
Regulation Number882.5897
Classification Product Code
Date Received05/17/2017
Decision Date 04/26/2018
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct