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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, biofeedback
Product CodeHCC
Regulation Number 882.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
GRAYMATTERS HEALTH LTD.
  SUBSTANTIALLY EQUIVALENT 1
PALO ALTO HEALTH SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 6 6
2020 1 1
2022 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Break 2 2
Nonstandard Device 1 1
Material Rupture 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Sleep Dysfunction 4 4
Foreign Body In Patient 2 2
Shaking/Tremors 2 2
Tachycardia 2 2
Brain Injury 2 2
Anxiety 1 1
Reaction 1 1
Dysphasia 1 1
Abdominal Pain 1 1
Diarrhea 1 1
Fall 1 1
Headache 1 1
Muscle Spasm(s) 1 1
Muscular Rigidity 1 1
Pain 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
Confusion/ Disorientation 1 1
Vascular System (Circulation), Impaired 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ondamed Inc II May-10-2018
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