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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cranial electrotherapy stimulator to treat depression
Product CodeJXK
Regulation Number 882.5800
Device Class 3

MDR Year MDR Reports MDR Events
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fatigue 1 1
Headache 1 1
Weakness 1 1
Shaking/Tremors 1 1

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