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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 SYSTEMS TECHNOLOGY, INC. (DBA TACTILE MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
VENA GROUP, LLC
  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 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 54 54
Adverse Event Without Identified Device or Use Problem 27 27
Insufficient Information 24 24
Material Frayed 24 24
Sparking 17 17
Protective Measures Problem 10 10
Therapeutic or Diagnostic Output Failure 9 9
Electrical Power Problem 8 8
Fire 7 7
Use of Device Problem 7 7
Failure to Reset 7 7
Arcing 6 6
Communication or Transmission Problem 5 5
Inflation Problem 5 5
Break 5 5
Appropriate Term/Code Not Available 5 5
Calibration Problem 4 4
Output Problem 4 4
Temperature Problem 4 4
Display or Visual Feedback Problem 4 4
Electrical /Electronic Property Problem 4 4
No Audible Alarm 4 4
Defective Device 4 4
Device Displays Incorrect Message 3 3
Smoking 3 3
No Apparent Adverse Event 3 3
Electrical Shorting 3 3
Pressure Problem 3 3
Noise, Audible 2 2
Flare or Flash 2 2
Positioning Problem 2 2
Patient-Device Incompatibility 2 2
Detachment of Device or Device Component 2 2
Failure to Power Up 2 2
Increase in Pressure 2 2
Device Emits Odor 2 2
Leak/Splash 2 2
Mechanical Problem 2 2
Melted 1 1
Misconnection 1 1
Energy Output Problem 1 1
Device Alarm System 1 1
False Alarm 1 1
Thermal Decomposition of Device 1 1
Failure to Cycle 1 1
Deflation Problem 1 1
Material Puncture/Hole 1 1
Failure to Run on Battery 1 1
Defective Component 1 1
Component Missing 1 1
Structural Problem 1 1
Device Markings/Labelling Problem 1 1
Device Sensing Problem 1 1
Under-Sensing 1 1
Gas/Air Leak 1 1
Human-Device Interface Problem 1 1
Patient Device Interaction Problem 1 1
Audible Prompt/Feedback Problem 1 1
Incomplete or Inadequate Connection 1 1
Reset Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 58
No Known Impact Or Consequence To Patient 47 47
No Consequences Or Impact To Patient 37 37
No Patient Involvement 33 33
Pressure Sores 22 22
Insufficient Information 22 22
Thrombosis 8 8
Thrombosis/Thrombus 7 7
Nerve Damage 4 4
Pain 4 4
Electric Shock 4 4
Pulmonary Embolism 3 3
Tissue Damage 3 3
Stroke/CVA 3 3
Erythema 2 2
Bone Fracture(s) 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Rash 2 2
Bruise/Contusion 2 2
Burn(s) 2 2
No Information 2 2
Discomfort 2 2
Injury 2 2
Skin Inflammation/ Irritation 2 2
Swelling 2 2
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Localized Skin Lesion 1 1
Impaired Healing 1 1
Inadequate Pain Relief 1 1
Numbness 1 1
Sweating 1 1
Shaking/Tremors 1 1
Skin Tears 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Hypervolemia 1 1
Alteration In Body Temperature 1 1
Vascular System (Circulation), Impaired 1 1
Distress 1 1
Loss of Range of Motion 1 1
Local Reaction 1 1
Skin Discoloration 1 1
Ischemia 1 1
Infarction, Cerebral 1 1
Dyspnea 1 1
Embolism 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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