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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device sleeve, limb, compressible
Product CodeJOW
Regulation Number 870.5800
Device Class 2


Premarket Reviews
ManufacturerDecision
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 3
CAREMED SUPPLY, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  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 3
DIMEDI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EEZCARE MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 2
GETINGE (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU LONGEST SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNTLEIGH HEALTHCARE 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 1
KOYA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
KOYA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MANAMED, INC
  SUBSTANTIALLY EQUIVALENT 1
MANAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDI USA, L.P.
  SUBSTANTIALLY EQUIVALENT 1
MEDI USA, LP
  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 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
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 1
SUZHOU MINHUA MEDICAL APPARATUS SUPPLIES CO. LTD.
  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
2017 149 149
2018 114 114
2019 102 102
2020 50 50
2021 34 34
2022 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 55 55
Temperature Problem 51 51
Cut In Material 41 41
Split 39 39
Adverse Event Without Identified Device or Use Problem 32 32
Thermal Decomposition of Device 28 28
Material Frayed 25 25
Insufficient Information 24 24
Power Problem 19 19
Sparking 16 16
Improper Flow or Infusion 15 15
Appropriate Term/Code Not Available 15 15
Break 12 12
Infusion or Flow Problem 11 11
Use of Device Problem 10 10
Electrical /Electronic Property Problem 9 9
Electrical Power Problem 9 9
Fire 8 8
Arcing 7 7
Inflation Problem 6 6
Smoking 5 5
Electrical Shorting 4 4
Device Operates Differently Than Expected 4 4
Material Protrusion/Extrusion 4 4
Pressure Problem 4 4
Device Emits Odor 4 4
Mechanical Problem 3 3
Deflation Problem 3 3
Detachment Of Device Component 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Damaged by Another Device 3 3
Component Missing 3 3
Defective Device 3 3
Device Displays Incorrect Message 3 3
Noise, Audible 3 3
Patient Device Interaction Problem 2 2
Positioning Problem 2 2
Detachment of Device or Device Component 2 2
Patient-Device Incompatibility 2 2
Communication or Transmission Problem 2 2
Flare or Flash 2 2
No Apparent Adverse Event 2 2
Air Leak 2 2
Disconnection 2 2
Display or Visual Feedback Problem 2 2
Melted 2 2
Leak/Splash 2 2
Improper or Incorrect Procedure or Method 2 2
Electro-Static Discharge 2 2
Failure to Power Up 2 2
Increase in Pressure 2 2
Material Puncture/Hole 1 1
Therapy Delivered to Incorrect Body Area 1 1
Shielding Failure 1 1
Device Slipped 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Loose or Intermittent Connection 1 1
Misconnection 1 1
Energy Output Problem 1 1
Failure to Run on Battery 1 1
Charred 1 1
Hole In Material 1 1
Device Alarm System 1 1
No Audible Alarm 1 1
Bent 1 1
Component Falling 1 1
Computer Software Problem 1 1
Crack 1 1
Protective Measures Problem 1 1
Physical Property Issue 1 1
Gas/Air Leak 1 1
Human-Device Interface Problem 1 1
Device Sensing Problem 1 1
Device-Device Incompatibility 1 1
Delamination 1 1
Structural Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Under-Sensing 1 1
Material Split, Cut or Torn 1 1
Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 107 107
No Consequences Or Impact To Patient 95 95
No Known Impact Or Consequence To Patient 86 86
No Information 68 68
No Clinical Signs, Symptoms or Conditions 27 27
Pressure Sores 19 19
Injury 10 10
Thrombosis 9 9
Insufficient Information 8 8
Nerve Damage 7 7
Pain 6 6
Erythema 5 5
Electric Shock 5 5
Pulmonary Embolism 4 4
Bruise/Contusion 4 4
Rash 4 4
Swelling 4 4
Tissue Damage 3 3
Edema 3 3
Stroke/CVA 3 3
Discomfort 3 3
Thrombosis/Thrombus 2 2
Skin Inflammation/ Irritation 2 2
Numbness 2 2
Burn(s) 2 2
Bone Fracture(s) 2 2
Hematoma 2 2
Hyperemia 2 2
Skin Discoloration 2 2
Local Reaction 1 1
Peripheral Vascular Disease 1 1
Pulmonary Edema 1 1
Loss of Range of Motion 1 1
Weakness 1 1
Distress 1 1
Impaired Healing 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
Unspecified Infection 1 1
Ischemia 1 1
Laceration(s) 1 1
Hemorrhage/Bleeding 1 1
Embolism 1 1
Infarction, Cerebral 1 1
Cyanosis 1 1
Death 1 1
Dyspnea 1 1
Sweating 1 1
Post Operative Wound Infection 1 1
Shaking/Tremors 1 1
Skin Tears 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Vascular System (Circulation), Impaired 1 1
Alteration In Body Temperature 1 1
Patient Problem/Medical Problem 1 1
Swelling/ Edema 1 1
Not Applicable 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 Dec-21-2017
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