Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 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

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 54 54
Cut In Material 39 39
Adverse Event Without Identified Device or Use Problem 35 35
Insufficient Information 27 27
Temperature Problem 25 25
Material Frayed 24 24
Sparking 19 19
Thermal Decomposition of Device 13 13
Power Problem 11 11
Use of Device Problem 11 11
Protective Measures Problem 10 10
Electrical Power Problem 9 9
Therapeutic or Diagnostic Output Failure 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
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74 74
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
Pressure Sores 24 24
Insufficient Information 24 24
Thrombosis 9 9
Thrombosis/Thrombus 8 8
Nerve Damage 7 7
Electric Shock 6 6
Pain 6 6
Injury 5 5
Bruise/Contusion 4 4
Pulmonary Embolism 4 4
Rash 4 4
Stroke/CVA 3 3
Tissue Damage 3 3
Bone Fracture(s) 3 3
Erythema 3 3
Burn(s) 3 3
Hemorrhage/Bleeding 2 2
Discomfort 2 2
Swelling 2 2
Numbness 2 2
Hematoma 2 2
Skin Inflammation/ Irritation 2 2
Hip Fracture 2 2
Impaired Healing 2 2
Skin Discoloration 1 1
Alteration In Body Temperature 1 1
Blister 1 1
Localized Skin Lesion 1 1
Local Reaction 1 1
Edema 1 1
Ischemia 1 1
Loss of Range of Motion 1 1
Dyspnea 1 1
Laceration(s) 1 1
Pulmonary Edema 1 1
Vascular System (Circulation), Impaired 1 1
Shaking/Tremors 1 1
Swelling/ Edema 1 1
Unspecified Tissue Injury 1 1
Embolism 1 1
Skin Tears 1 1
Sweating 1 1
Infarction, Cerebral 1 1
Inadequate Pain Relief 1 1
Hypoesthesia 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
-
-