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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 4
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 4
CARDINAL HEALTH200, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAREMED SUPPLY, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
CURRIE MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
DAESUNG MAREF CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
DAESUNG MAREF CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEVON MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
DEVON MEDICAL PRODUCTS (JIANGSU) LTD
  SUBSTANTIALLY EQUIVALENT 3
DEVON MEDICAL PRODUCTS (JIANGSU) LTD.
  SUBSTANTIALLY EQUIVALENT 3
DIMEDI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EEZCARE MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 2
ELASTIMED LTD.
  SUBSTANTIALLY EQUIVALENT 1
GETINGE (SUZHOU) CO., 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 2
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 2
MANAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDHEALTH MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDI USA, L.P.
  SUBSTANTIALLY EQUIVALENT 1
MEDI USA, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPRESSION SYSTEM (DBN) LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEGO AFEK AC LTD.
  SUBSTANTIALLY EQUIVALENT 4
MIDWAY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
NORMATEC INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
ORTHO8 INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHO8, INC.
  SUBSTANTIALLY EQUIVALENT 1
PEGASUS MEDICAL SUPPLY, INC.
  SUBSTANTIALLY EQUIVALENT 2
PULSEFLOW TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
RADIAL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
RECOVERY FORCE LLC
  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
SURGICAL INSTRUMENT SERVICE AND SAVINGS (DBA MEDLINE RENEWAL
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU MINHUA MEDICAL APPARATUS SUPPLIES CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
TACTILE SYSTEMS TECHNOLOGY INC
  SUBSTANTIALLY EQUIVALENT 1
TACTILE SYSTEMS TECHNOLOGY, INC (DBA TACTILE MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
TACTILE SYSTEMS TECHNOLOGY, INC. (DBA TACTILE MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
VENA GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 137 137
2016 150 150
2017 149 149
2018 114 114
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
Break 116 116
Electrical /Electronic Property Problem 77 77
Scratched Material 63 63
Adverse Event Without Identified Device or Use Problem 61 61
Overheating of Device 55 55
Thermal Decomposition of Device 54 54
Temperature Problem 52 52
Cut In Material 49 49
Insufficient Information 43 43
Split 39 39
Material Frayed 26 26
Sparking 25 25
Improper Flow or Infusion 22 22
Power Problem 21 21
Infusion or Flow Problem 18 18
Device Operates Differently Than Expected 17 17
Device Displays Incorrect Message 16 16
Use of Device Problem 15 15
Appropriate Term/Code Not Available 15 15
Fire 14 14
Smoking 12 12
Protective Measures Problem 10 10
Therapeutic or Diagnostic Output Failure 9 9
Electrical Power Problem 9 9
Arcing 8 8
Material Protrusion/Extrusion 7 7
Failure to Reset 7 7
Inflation Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Failure to Power Up 6 6
Device Emits Odor 6 6
Noise, Audible 6 6
Mechanical Problem 6 6
Disconnection 6 6
Display or Visual Feedback Problem 5 5
Pressure Problem 5 5
Electrical Shorting 5 5
Leak/Splash 5 5
Communication or Transmission Problem 5 5
Component Missing 4 4
No Audible Alarm 4 4
Melted 4 4
Calibration Problem 4 4
Defective Device 4 4
Charred 4 4
Output Problem 4 4
Detachment of Device or Device Component 3 3
Crack 3 3
Positioning Problem 3 3
Malposition of Device 3 3
Inadequacy of Device Shape and/or Size 3 3
Detachment Of Device Component 3 3
Device Damaged by Another Device 3 3
Material Too Rigid or Stiff 3 3
No Apparent Adverse Event 3 3
Deflation Problem 3 3
Increase in Pressure 3 3
Electro-Static Discharge 3 3
Battery Problem 3 3
Flare or Flash 2 2
Bent 2 2
Patient-Device Incompatibility 2 2
Failure to Charge 2 2
No Display/Image 2 2
Physical Property Issue 2 2
Hole In Material 2 2
Pumping Problem 2 2
Loss of Power 2 2
Air Leak 2 2
Patient Device Interaction Problem 2 2
Loose or Intermittent Connection 2 2
Device Alarm System 2 2
Failure To Run On AC/DC 2 2
Torn Material 2 2
Device Slipped 1 1
Naturally Worn 1 1
Low Audible Alarm 1 1
Device Damaged Prior to Use 1 1
Computer Software Problem 1 1
Audible Prompt/Feedback Problem 1 1
Component Falling 1 1
Device Markings/Labelling Problem 1 1
Electromagnetic Interference 1 1
Device Handling Problem 1 1
Under-Sensing 1 1
Device-Device Incompatibility 1 1
Fail-Safe Design Failure 1 1
Therapy Delivered to Incorrect Body Area 1 1
Incomplete or Inadequate Connection 1 1
Reset Problem 1 1
Fitting Problem 1 1
Degraded 1 1
Delamination 1 1
Shielding Failure 1 1
Structural Problem 1 1
Material Puncture/Hole 1 1
Material Split, Cut or Torn 1 1
Device Dislodged or Dislocated 1 1
Failure to Run on Battery 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 271 271
No Patient Involvement 120 120
No Consequences Or Impact To Patient 110 110
No Information 79 79
No Clinical Signs, Symptoms or Conditions 58 58
Pressure Sores 34 34
Insufficient Information 22 22
Thrombosis 17 17
Pain 13 13
Injury 12 12
Swelling 10 10
Nerve Damage 8 8
Skin Discoloration 7 7
Cellulitis 7 7
Thrombosis/Thrombus 7 7
Electric Shock 7 7
Bruise/Contusion 6 6
Erythema 6 6
Rash 5 5
Pulmonary Embolism 5 5
Death 4 4
Hematoma 4 4
Fall 4 4
Discomfort 4 4
Tissue Damage 3 3
Reaction 3 3
Bone Fracture(s) 3 3
Skin Irritation 3 3
Hemorrhage/Bleeding 3 3
Edema 3 3
Burn(s) 3 3
Stroke/CVA 3 3
Hyperemia 2 2
Unspecified Infection 2 2
Itching Sensation 2 2
Numbness 2 2
Vascular System (Circulation), Impaired 2 2
Peroneal Nerve Palsy 2 2
Impaired Healing 2 2
Skin Inflammation/ Irritation 2 2
No Code Available 2 2
Not Applicable 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Localized Skin Lesion 1 1
Inadequate Pain Relief 1 1
Hypervolemia 1 1
Alteration In Body Temperature 1 1
Patient Problem/Medical Problem 1 1
Skin Inflammation 1 1
Sweating 1 1
Post Operative Wound Infection 1 1
Post Traumatic Wound Infection 1 1
Shaking/Tremors 1 1
Skin Tears 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Weakness 1 1
Distress 1 1
Complaint, Ill-Defined 1 1
Fracture, Arm 1 1
Laceration(s) 1 1
Peripheral Vascular Disease 1 1
Phlebitis 1 1
Pulmonary Edema 1 1
Loss of Range of Motion 1 1
Sprain 1 1
Local Reaction 1 1
Respiratory Distress 1 1
Thrombus 1 1
Ischemia 1 1
Embolism 1 1
Dyspnea 1 1
Infarction, Cerebral 1 1
Contusion 1 1
Cyanosis 1 1
Wound Dehiscence 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arjo, Inc. dba ArjoHuntleigh II Jun-26-2017
2 COVIDIEN LLC II Mar-22-2019
3 Compass Health Brands (Corporate Office) II May-15-2019
4 DJO, LLC II Jul-18-2019
5 Ortho8, Inc. II Aug-19-2021
6 Stryker Sustainability Solutions II May-19-2023
7 Stryker Sustainability Solutions II Dec-21-2017
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