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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
DEEPWELL DTX INC.
  SUBSTANTIALLY EQUIVALENT 1
GRAYMATTERS HEALTH LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 1 1
2022 3 3
2023 2 2
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6 6
Break 2 2
Patient Device Interaction Problem 1 1
Material Rupture 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Sleep Dysfunction 6 6
Anxiety 3 3
Shaking/Tremors 3 3
Brain Injury 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Foreign Body In Patient 2 2
Insufficient Information 2 2
Abdominal Pain 1 1
Dysphasia 1 1
Fatigue 1 1
Unspecified Gastrointestinal Problem 1 1
Memory Loss/Impairment 1 1
Inflammation 1 1
Muscle Weakness 1 1
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
No Known Impact Or Consequence To Patient 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Diarrhea 1 1
Muscle Spasm(s) 1 1
Muscular Rigidity 1 1
Depression 1 1
Numbness 1 1
Alteration in Body Temperature 1 1
Fall 1 1
Pain 1 1
Reaction 1 1
Tachycardia 1 1
Vascular System (Circulation), Impaired 1 1
Cough 1 1
Headache 1 1
Tinnitus 1 1
Hormonal Imbalance 1 1

Recalls
Manufacturer Recall Class Date Posted
1 RONAN MEDICAL LLC II Aug-27-2024
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