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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 , LTD.
  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
2026 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 27 27
Insufficient Information 27 27
Sparking 13 13
Melted 11 11
Protective Measures Problem 10 10
Therapeutic or Diagnostic Output Failure 10 10
Failure to Reset 7 7
Use of Device Problem 7 7
Temperature Problem 5 5
Communication or Transmission Problem 5 5
Display or Visual Feedback Problem 4 4
Calibration Problem 4 4
No Audible Alarm 4 4
Defective Device 4 4
Output Problem 4 4
Fire 4 4
Inflation Problem 3 3
No Apparent Adverse Event 3 3
Increase in Pressure 3 3
Arcing 3 3
Device Displays Incorrect Message 3 3
Positioning Problem 2 2
Gas/Air Leak 2 2
Appropriate Term/Code Not Available 2 2
Overheating of Device 2 2
Pressure Problem 2 2
Patient-Device Incompatibility 1 1
Smoking 1 1
Defective Component 1 1
Material Puncture/Hole 1 1
Energy Output Problem 1 1
Device Markings/Labelling Problem 1 1
Failure to Deliver 1 1
Patient Device Interaction Problem 1 1
Battery Problem 1 1
Incomplete or Inadequate Connection 1 1
Structural Problem 1 1
Audible Prompt/Feedback Problem 1 1
Lack of Effect 1 1
False Alarm 1 1
Mechanical Problem 1 1
Material Deformation 1 1
Device Sensing Problem 1 1
Electrical Shorting 1 1
Under-Sensing 1 1
Unexpected Shutdown 1 1
Failure to Cycle 1 1
Reset Problem 1 1
Connection Problem 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 88 88
Insufficient Information 26 26
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
Stroke/CVA 3 3
Impaired Healing 2 2
Hip Fracture 2 2
Skin Inflammation/ Irritation 2 2
Bone Fracture(s) 2 2
Embolism/Embolus 2 2
Rash 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
Chest Pain 1 1
Loss of Range of Motion 1 1
Laceration(s) 1 1
Choking 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Hypoesthesia 1 1
Inadequate Pain Relief 1 1
Tissue Breakdown 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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