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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 3
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
EVOLYM, LLC
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU LONGEST MEDICAL TECHNOLOGY CO., 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 2
THERMABRIGHT
  SUBSTANTIALLY EQUIVALENT 1
UNITED MEDICAL RESOURCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
VISTAR MEDICAL SUPPLIES CO., LTD.
  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 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 28 28
Insufficient Device Problem Information 27 27
Sparking 13 13
Melted 13 13
Use of Device Problem 7 7
Temperature Problem 5 5
Communication or Transmission Problem 5 5
Failure to Charge 4 4
Fire 4 4
Increase in Pressure 4 4
Inflation Problem 4 4
Arcing 3 3
No Apparent Adverse Event 3 3
Power Problem 2 2
Appropriate Device Problem Term/Code Not Available 2 2
Electrical Shorting 2 2
Patient Device Interaction Problem 2 2
Failure to Deliver 2 2
Positioning Problem 2 2
Aborted Charge 2 2
Failure to Power Up 1 1
Battery Problem 1 1
Charging Problem 1 1
Visual Prompts will not Clear 1 1
Lack of Effect 1 1
False Alarm 1 1
Failure to Pump 1 1
Failure to Select Signal 1 1
Therapeutic or Diagnostic Output Failure 1 1
Defective Alarm 1 1
Unintended Power Up 1 1
Failure to Cycle 1 1
Incomplete or Inadequate Connection 1 1
Unexpected Therapeutic Results 1 1
Human-Device Interface Problem 1 1
Overheating of Device 1 1
Electrical /Electronic Property Problem 1 1
Loose or Intermittent Connection 1 1
Improper or Incorrect Procedure or Method 1 1
Pressure Problem 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 100 100
Insufficient Information 37 37
Pressure Sore/Ulcer 26 26
Thrombosis/Thrombus 9 9
Bruise/Contusion 6 6
Pain 5 5
Burn(s) 5 5
Nerve Damage 5 5
Electric Shock 4 4
Hematoma 4 4
Impaired Healing 3 3
Stroke/CVA 3 3
Pulmonary Embolism 3 3
Skin Inflammation/ Irritation 3 3
Bone Fracture(s) 3 3
Blister 3 3
Tissue Breakdown 2 2
Deformity/ Disfigurement 2 2
Swelling/ Edema 2 2
Unspecified Tissue Injury 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
Fall 2 2
Discomfort 2 2
Rash 2 2
Skin Discoloration 2 2
Embolism/Embolus 2 2
Diaphoresis 2 2
Hip Fracture 2 2
Chest Pain 1 1
Loss of Range of Motion 1 1
Ambulation or Postural Difficulties 1 1
Cardiac Arrest 1 1
Peripheral Edema 1 1
Laceration(s) 1 1
Skin Disorders 1 1
Localized Skin Lesion 1 1
Choking 1 1
Itching Sensation 1 1
Hot Flashes/Flushes 1 1
Hypoesthesia 1 1
Ischemia 1 1
Inadequate Pain Relief 1 1
Wound Odor 1 1
Reduced Blood Flow 1 1
Unspecified Skin and Subcutaneous Tissue Problem 1 1
Distress 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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