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


Premarket Reviews
ManufacturerDecision
AIROS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
APEX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIO COMPRESSION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOTAB, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH200, LLC
  SUBSTANTIALLY EQUIVALENT 1
DAESUNG MAREF CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EEZCARE MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 1
ELASTIMED , LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNTLEIGH HEALTHCARE , LTD.
  SUBSTANTIALLY EQUIVALENT 1
IG TECHNOLOGY, LTD.
  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
MANAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
MANAMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDHEALTH MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDI USA, LP
  SUBSTANTIALLY EQUIVALENT 1
MEGO AFEK AC , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO8, INC.
  SUBSTANTIALLY EQUIVALENT 3
RECOVERY FORCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
RENU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN PANGO ELECTRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUN SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU MINHUA MEDICAL APPARATUS SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TACTILE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
THERMABRIGHT
  SUBSTANTIALLY EQUIVALENT 1
UNITED MEDICAL RESOURCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
VIVE HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
WELLELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZENITH TECHNICAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 34 34
2022 27 27
2023 57 57
2024 30 30
2025 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 26 26
Insufficient Information 25 25
Sparking 13 13
Protective Measures Problem 10 10
Therapeutic or Diagnostic Output Failure 9 9
Melted 7 7
Failure to Reset 7 7
Use of Device Problem 7 7
Temperature Problem 5 5
Communication or Transmission Problem 5 5
Fire 4 4
Display or Visual Feedback Problem 4 4
Output Problem 4 4
Calibration Problem 4 4
No Audible Alarm 4 4
Device Displays Incorrect Message 3 3
Arcing 3 3
No Apparent Adverse Event 3 3
Inflation Problem 3 3
Overheating of Device 2 2
Appropriate Term/Code Not Available 2 2
Increase in Pressure 2 2
Positioning Problem 2 2
Defective Device 2 2
Pressure Problem 2 2
Battery Problem 1 1
Gas/Air Leak 1 1
Structural Problem 1 1
Failure to Deliver 1 1
Audible Prompt/Feedback Problem 1 1
Lack of Effect 1 1
False Alarm 1 1
Material Deformation 1 1
Defective Component 1 1
Device Sensing Problem 1 1
Electrical Shorting 1 1
Smoking 1 1
Patient-Device Incompatibility 1 1
Under-Sensing 1 1
Material Puncture/Hole 1 1
Energy Output Problem 1 1
Failure to Cycle 1 1
Device Markings/Labelling Problem 1 1
Human-Device Interface Problem 1 1
Incomplete or Inadequate Connection 1 1
Mechanical Problem 1 1
Loose or Intermittent Connection 1 1
Reset Problem 1 1
Failure to Run on Battery 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 81 81
Insufficient Information 24 24
Pressure Sores 23 23
Thrombosis/Thrombus 9 9
Burn(s) 5 5
Nerve Damage 5 5
Pain 5 5
Electric Shock 4 4
Hematoma 4 4
Impaired Healing 2 2
Stroke/CVA 2 2
Hip Fracture 2 2
Skin Inflammation/ Irritation 2 2
Bone Fracture(s) 2 2
Embolism/Embolus 2 2
Hemorrhage/Bleeding 2 2
Pulmonary Embolism 2 2
Bruise/Contusion 2 2
Ischemia 1 1
Blister 1 1
Localized Skin Lesion 1 1
Cardiac Arrest 1 1
Skin Discoloration 1 1
Rash 1 1
Loss of Range of Motion 1 1
Laceration(s) 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Hypoesthesia 1 1
Inadequate Pain Relief 1 1
Distress 1 1
Ambulation Difficulties 1 1
Hypervolemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Jun-06-2025
2 Ortho8, Inc. II Aug-19-2021
3 Stryker Sustainability Solutions II May-19-2023
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