TPLC - Total Product Life Cycle

• 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
2019	6	6
2020	2	2
2022	3	3
2023	2	2
2024	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Sleep Dysfunction	6	6
Anxiety	3	3
Shaking/Tremors	3	3
Dysphasia	2	2
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
Muscle Weakness/Atrophy	1	1
Weight Changes	1	1
Fatigue	1	1
No Code Available	1	1
Unspecified Gastrointestinal Problem	1	1
Memory Loss/Impairment	1	1
Inflammation	1	1
Abdominal Distention	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