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TPLC
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Device
device, biofeedback
Regulation Description
Biofeedback device.
Product Code
HCC
Regulation Number
882.5050
Device Class
2
Premarket Reviews
Manufacturer
Decision
DEEPWELL DTX INC.
SUBSTANTIALLY EQUIVALENT
1
GRAYMATTERS HEALTH LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
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
3
3
Patient Device Interaction Problem
1
1
Nonstandard Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Sleep Dysfunction
5
5
Anxiety
2
2
No Clinical Signs, Symptoms or Conditions
2
2
Shaking/Tremors
2
2
Insufficient Information
2
2
Brain Injury
1
1
Diarrhea
1
1
Fall
1
1
Muscle Weakness
1
1
Hormonal Imbalance
1
1
Alteration in Body Temperature
1
1
Inflammation
1
1
Cough
1
1
Abdominal Pain
1
1
Depression
1
1
Tinnitus
1
1
Memory Loss/Impairment
1
1
Muscular Rigidity
1
1
Tachycardia
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Headache
1
1
Numbness
1
1
Fatigue
1
1
Unspecified Gastrointestinal Problem
1
1
Cognitive Changes
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
RONAN MEDICAL LLC
II
Aug-27-2024
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