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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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Device sleeve, limb, compressible
Regulation Description Compressible limb sleeve.
Product CodeJOW
Regulation Number 870.5800
Device Class 2


Premarket Reviews
ManufacturerDecision
ARJOHUNTLEIGH AB
  SUBSTANTIALLY EQUIVALENT 1
BIO COMPRESSION SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 3
BIO COMPRESSION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CAREMED SUPPLY INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
CURRIE MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
DAESUNG MAREF CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEVON MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 2
DEVON MEDICAL PRODUCTS (JIANGSU) LTD
  SUBSTANTIALLY EQUIVALENT 3
HEALTHCARE SERVICE AND SUPPLY
  SUBSTANTIALLY EQUIVALENT 2
INNOVAMED HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
INOVA LABS
  SUBSTANTIALLY EQUIVALENT 1
MEDI USA, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NORMATEC INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
RECOVERY FORCE LLC
  SUBSTANTIALLY EQUIVALENT 1
TACTILE SYSTEMS TECHNOLOGY INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Overheating of Device 53
Temperature Problem 46
Power Cord 45
Cut In Material 42
Split 39
Adverse Event Without Identified Device or Use Problem 36
Break 35
Thermal Decomposition of Device 31
Electrical /Electronic Property Problem 27
Wire 24
Improper Flow or Infusion 22
Material Frayed 21
Power Problem 19
Scratched Material 18
Infusion or Flow Problem 18
Electrical Wire 14
Appropriate Term/Code Not Available 13
Use of Device Problem 9
Electrical Power Problem 9
Insufficient Information 7
Sparking 7
Fire 6
Smoking 6
Device Displays Incorrect Message 5
Improper or Incorrect Procedure or Method 4
Charred 3
Arcing 3
Power Switch 3
Device Damaged by Another Device 3
Inflation Problem 3
Electro-Static Discharge 2
Plug 2
Flare or Flash 2
Deflation Problem 2
Failure to Power Up 2
Patient Device Interaction Problem 2
Cord 2
Detachment Of Device Component 2
Disconnection 2
Device Emits Odor 2
Pumping Problem 2
Electrical Shorting 2
Pressure Problem 2
Pin 2
Degraded 1
Alarm 1
Alarm, Audible 1
Fuse 1
Unit 1
Material Split, Cut or Torn 1
No Display / Image 1
Component Missing 1
Delamination 1
Detachment of Device or device Component 1
Therapy Delivered to Incorrect Body Area 1
Device Damaged Prior to Use 1
Display 1
Inadequacy of Device Shape and/or Size 1
Housing 1
Failure To Run On AC/DC 1
Melted 1
Misconnection 1
Device Operates Differently Than Expected 1
Torn Material 1
Device Handling Problem 1
Device Alarm System 1
Total Device Problems 621

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 Stryker Sustainability Solutions II Dec-21-2017

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