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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sleeve, limb, compressible
Product CodeJOW
Regulation Number 870.5800
Device Class 2


Premarket Reviews
ManufacturerDecision
AIROS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 2
AIROS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 1
CARDINAL HEALTH200, LLC
  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 2
DIMEDI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EEZCARE MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 2
ELASTIMED 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
ORTHO8 INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHO8, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADIAL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
TACTILE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TACTILE SYSTEMS TECHNOLOGY, INC. (DBA TACTILE MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
THERMABRIGHT
  SUBSTANTIALLY EQUIVALENT 1
VENA GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZENITH TECHNICAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 102 102
2020 50 50
2021 34 34
2022 27 27
2023 57 57
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 54 54
Adverse Event Without Identified Device or Use Problem 31 31
Material Frayed 24 24
Insufficient Information 24 24
Sparking 18 18
Protective Measures Problem 10 10
Therapeutic or Diagnostic Output Failure 9 9
Fire 8 8
Electrical Power Problem 8 8
Use of Device Problem 8 8
Failure to Reset 7 7
Arcing 6 6
Temperature Problem 5 5
Break 5 5
Communication or Transmission Problem 5 5
Appropriate Term/Code Not Available 5 5
Inflation Problem 5 5
Output Problem 4 4
Electrical /Electronic Property Problem 4 4
Display or Visual Feedback Problem 4 4
Defective Device 4 4
No Audible Alarm 4 4
Calibration Problem 4 4
Pressure Problem 3 3
Device Displays Incorrect Message 3 3
Smoking 3 3
No Apparent Adverse Event 3 3
Electrical Shorting 3 3
Noise, Audible 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
Failure to Power Up 2 2
Positioning Problem 2 2
Patient-Device Incompatibility 2 2
Mechanical Problem 2 2
Leak/Splash 2 2
Structural Problem 1 1
Thermal Decomposition of Device 1 1
Audible Prompt/Feedback Problem 1 1
Lack of Effect 1 1
False Alarm 1 1
Gas/Air Leak 1 1
Misconnection 1 1
Component Missing 1 1
Patient Device Interaction Problem 1 1
Device Sensing Problem 1 1
Deflation Problem 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 69 69
No Known Impact Or Consequence To Patient 47 47
No Consequences Or Impact To Patient 37 37
No Patient Involvement 33 33
Insufficient Information 23 23
Pressure Sores 22 22
Thrombosis/Thrombus 8 8
Thrombosis 8 8
Pain 5 5
Electric Shock 4 4
Nerve Damage 4 4
Stroke/CVA 3 3
Bruise/Contusion 3 3
Bone Fracture(s) 3 3
Pulmonary Embolism 3 3
Burn(s) 3 3
Tissue Damage 3 3
Hip Fracture 2 2
No Information 2 2
Skin Inflammation/ Irritation 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Rash 2 2
Injury 2 2
Swelling 2 2
Erythema 2 2
Discomfort 2 2
Hypervolemia 1 1
Ambulation Difficulties 1 1
Distress 1 1
Inadequate Pain Relief 1 1
Skin Tears 1 1
Embolism 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Shaking/Tremors 1 1
Vascular System (Circulation), Impaired 1 1
Dyspnea 1 1
Loss of Range of Motion 1 1
Numbness 1 1
Skin Discoloration 1 1
Alteration In Body Temperature 1 1
Blister 1 1
Localized Skin Lesion 1 1
Local Reaction 1 1
Ischemia 1 1
Sweating 1 1
Infarction, Cerebral 1 1
Impaired Healing 1 1
Sleep Dysfunction 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
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