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
Regulation Description Compressible limb sleeve.
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
  1.  K203310  SyneCare 1000 Deep Vein Thrombosis Prevention Ther ...
  2.  K211937  SyneCare 1100 Deep Vein Thrombosis Prevention Ther ...
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
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 55 55
Cut In Material 39 39
Adverse Event Without Identified Device or Use Problem 38 38
Insufficient Information 29 29
Temperature Problem 25 25
Material Frayed 24 24
Sparking 20 20
Use of Device Problem 13 13
Thermal Decomposition of Device 13 13
Power Problem 11 11
Therapeutic or Diagnostic Output Failure 10 10
Protective Measures Problem 10 10
Electrical Power Problem 9 9
Break 8 8
Fire 8 8
Split 8 8
Failure to Reset 7 7
Arcing 7 7
Appropriate Term/Code Not Available 6 6
Inflation Problem 6 6
Electrical /Electronic Property Problem 6 6
Pressure Problem 5 5
Display or Visual Feedback Problem 5 5
Communication or Transmission Problem 5 5
Output Problem 4 4
No Audible Alarm 4 4
Defective Device 4 4
Device Displays Incorrect Message 4 4
Calibration Problem 4 4
No Apparent Adverse Event 3 3
Electrical Shorting 3 3
Smoking 3 3
Patient-Device Incompatibility 2 2
Detachment of Device or Device Component 2 2
Patient Device Interaction Problem 2 2
Disconnection 2 2
Flare or Flash 2 2
Noise, Audible 2 2
Deflation Problem 2 2
Leak/Splash 2 2
Mechanical Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Device Emits Odor 2 2
Failure to Power Up 2 2
Increase in Pressure 2 2
Component Missing 2 2
Detachment Of Device Component 2 2
Air Leak 2 2
Positioning Problem 2 2
Lack of Effect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 76 76
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
Insufficient Information 26 26
Pressure Sores 24 24
Thrombosis 9 9
Nerve Damage 8 8
Thrombosis/Thrombus 8 8
Electric Shock 7 7
Pain 6 6
Burn(s) 6 6
Injury 5 5
Pulmonary Embolism 5 5
Rash 4 4
Bruise/Contusion 4 4
Tissue Damage 3 3
Stroke/CVA 3 3
Erythema 3 3
Bone Fracture(s) 3 3
Discomfort 2 2
Swelling 2 2
Numbness 2 2
Impaired Healing 2 2
Hip Fracture 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Skin Inflammation/ Irritation 2 2
Distress 1 1
Skin Discoloration 1 1
Local Reaction 1 1
Loss of Range of Motion 1 1
Pulmonary Edema 1 1
Laceration(s) 1 1
Ischemia 1 1
Hypoesthesia 1 1
Swelling/ Edema 1 1
Unspecified Tissue Injury 1 1
Localized Skin Lesion 1 1
Blister 1 1
Embolism 1 1
Edema 1 1
Dyspnea 1 1
Infarction, Cerebral 1 1
Embolism/Embolus 1 1
Inadequate Pain Relief 1 1
Patient Problem/Medical Problem 1 1
Alteration In Body Temperature 1 1
Hypervolemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 COVIDIEN LLC II Mar-22-2019
2 Cardinal Health 200, LLC II Jun-06-2025
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
-
-