TPLC - Total Product Life Cycle

• Device: sleeve, limb, compressible
• Regulation Description: Compressible limb sleeve.
• Product Code: JOW
• Regulation Number: 870.5800
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AIROS MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	2
AIROS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	5
ALLEVA MEDICAL (D.G.) LTD
	SUBSTANTIALLY EQUIVALENT	1
APEX MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
B & J MANUFACTURING LTD
	SUBSTANTIALLY EQUIVALENT	1
B & J MANUFACTURING LTD.
	SUBSTANTIALLY EQUIVALENT	2
B&J MANUFACTURING LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIO COMPRESSION SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
CARDINAL HEALTH200, LLC
	SUBSTANTIALLY EQUIVALENT	1
CAREMED SUPPLY, INC.
	SUBSTANTIALLY EQUIVALENT	1
DAESUNG MAREF CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
DAESUNG MAREF CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DEVON MEDICAL PRODUCTS (JIANGSU) LTD
	SUBSTANTIALLY EQUIVALENT	3
DEVON MEDICAL PRODUCTS (JIANGSU) LTD.
	SUBSTANTIALLY EQUIVALENT	1
DIMEDI CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
EEZCARE MEDICAL CORP
	SUBSTANTIALLY EQUIVALENT	2
ELASTIMED LTD.
	SUBSTANTIALLY EQUIVALENT	1
GETINGE (SUZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU LONGEST SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUNTLEIGH HEALTHCARE LTD
	SUBSTANTIALLY EQUIVALENT	1
IG TECHNOLOGY LTD
	SUBSTANTIALLY EQUIVALENT	1
INNOVAMED HEALTH, LLC
	SUBSTANTIALLY EQUIVALENT	1
INOVA LABS
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU SYNECOUN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
JKH HEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
K&L DISTRIBUTING, INC.
	SUBSTANTIALLY EQUIVALENT	1
KOGE MICRO TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KOYA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
KOYA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MANAMED, INC
	SUBSTANTIALLY EQUIVALENT	1
MANAMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDHEALTH MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MEDI USA, L.P.
	SUBSTANTIALLY EQUIVALENT	1
MEDI USA, LP
	SUBSTANTIALLY EQUIVALENT	1
MEGO AFEK AC LTD.
	SUBSTANTIALLY EQUIVALENT	2
MIDWAY MEDICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	1
NORMATEC INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
ORTHO8 INC.
	SUBSTANTIALLY EQUIVALENT	2
ORTHO8, INC.
	SUBSTANTIALLY EQUIVALENT	1
PEGASUS MEDICAL SUPPLY, INC.
	SUBSTANTIALLY EQUIVALENT	1
RADIAL MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
RECOVERY FORCE, LLC
	SUBSTANTIALLY EQUIVALENT	1
RENU MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN PANGO ELECTRONIC CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SLK MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
SUN SCIENTIFIC INC
	SUBSTANTIALLY EQUIVALENT	2
SUZHOU MINHUA MEDICAL APPARATUS SUPPLIES CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU MINHUA MEDICAL APPARATUS SUPPLIES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TACTILE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TACTILE SYSTEMS TECHNOLOGY, INC. (DBA TACTILE MEDICAL)
	SUBSTANTIALLY EQUIVALENT	1
THERMABRIGHT
	SUBSTANTIALLY EQUIVALENT	1
UNITED MEDICAL RESOURCES LLC
	SUBSTANTIALLY EQUIVALENT	1
VENA GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZENITH TECHNICAL INNOVATIONS
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	114	114
2019	102	102
2020	50	50
2021	34	34
2022	27	27
2023	57	57
2024	30	30
2025	9	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	55	55
Cut In Material	39	39
Adverse Event Without Identified Device or Use Problem	36	36
Insufficient Information	29	29
Temperature Problem	25	25
Material Frayed	24	24
Sparking	20	20
Use of Device Problem	13	13
Thermal Decomposition of Device	13	13
Power Problem	11	11
Protective Measures Problem	10	10
Therapeutic or Diagnostic Output Failure	10	10
Electrical Power Problem	9	9
Break	8	8
Fire	8	8
Split	8	8
Arcing	7	7
Failure to Reset	7	7
Electrical /Electronic Property Problem	6	6
Appropriate Term/Code Not Available	6	6
Inflation Problem	6	6
Pressure Problem	5	5
Communication or Transmission Problem	5	5
Display or Visual Feedback Problem	5	5
Device Displays Incorrect Message	4	4
Output Problem	4	4
Defective Device	4	4
No Audible Alarm	4	4
Calibration Problem	4	4
Smoking	3	3
No Apparent Adverse Event	3	3
Electrical Shorting	3	3
Noise, Audible	2	2
Detachment Of Device Component	2	2
Improper or Incorrect Procedure or Method	2	2
Increase in Pressure	2	2
Detachment of Device or Device Component	2	2
Device Emits Odor	2	2
Flare or Flash	2	2
Component Missing	2	2
Failure to Power Up	2	2
Air Leak	2	2
Patient Device Interaction Problem	2	2
Deflation Problem	2	2
Positioning Problem	2	2
Patient-Device Incompatibility	2	2
Mechanical Problem	2	2
Leak/Splash	2	2
Disconnection	2	2
Gas/Air Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	76	76
No Consequences Or Impact To Patient	72	72
No Patient Involvement	69	69
No Known Impact Or Consequence To Patient	56	56
No Information	29	29
Insufficient Information	26	26
Pressure Sores	24	24
Thrombosis	9	9
Thrombosis/Thrombus	8	8
Electric Shock	7	7
Nerve Damage	7	7
Pain	6	6
Pulmonary Embolism	5	5
Burn(s)	5	5
Injury	5	5
Bruise/Contusion	4	4
Rash	4	4
Stroke/CVA	3	3
Bone Fracture(s)	3	3
Tissue Damage	3	3
Erythema	3	3
Impaired Healing	2	2
Hip Fracture	2	2
Skin Inflammation/ Irritation	2	2
Hematoma	2	2
Hemorrhage/Bleeding	2	2
Swelling	2	2
Discomfort	2	2
Numbness	2	2
Hypervolemia	1	1
Ambulation Difficulties	1	1
Distress	1	1
Inadequate Pain Relief	1	1
Hypoesthesia	1	1
Skin Tears	1	1
Embolism	1	1
Swelling/ Edema	1	1
Unspecified Tissue Injury	1	1
Vascular System (Circulation), Impaired	1	1
Shaking/Tremors	1	1
Pulmonary Edema	1	1
Laceration(s)	1	1
Dyspnea	1	1
Loss of Range of Motion	1	1
Alteration In Body Temperature	1	1
Skin Discoloration	1	1
Localized Skin Lesion	1	1
Blister	1	1
Local Reaction	1	1
Edema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	COVIDIEN LLC	II	Mar-22-2019
2	Compass Health Brands (Corporate Office)	II	May-15-2019
3	DJO, LLC	II	Jul-18-2019
4	Ortho8, Inc.	II	Aug-19-2021
5	Stryker Sustainability Solutions	II	May-19-2023