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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device external upper limb tremor stimulator
Regulation Description External upper limb tremor stimulator.
Definition An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb.
Product CodeQBC
Regulation Number 882.5897
Device Class 2


Premarket Reviews
ManufacturerDecision
CALA HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 4
ENCORA, INC.
  SUBSTANTIALLY EQUIVALENT 1
FASIKL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1
2023 1 1
2024 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Arrhythmia 1 1
Fatigue 1 1
Muscle Weakness 1 1
Burn, Thermal 1 1
Atrial Fibrillation 1 1
Confusion/ Disorientation 1 1
Chest Pain 1 1
Heart Failure/Congestive Heart Failure 1 1
Swelling/ Edema 1 1
Loss of consciousness 1 1

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