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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
B&J MANUFACTURING , LTD.
  SUBSTANTIALLY EQUIVALENT 4
BIO COMPRESSION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTAB, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH200, LLC
  SUBSTANTIALLY EQUIVALENT 1
DAESUNG MAREF CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DIMEDI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EEZCARE MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 2
ELASTIMED , 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
INOVA LABS
  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
KOYA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MANAMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 PANGO ELECTRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLK MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SUN SCIENTIFIC, INC.
  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
VIVE HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
WELLELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZENITH TECHNICAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 50 50
2021 34 34
2022 27 27
2023 57 57
2024 30 30
2025 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 33 33
Insufficient Information 27 27
Sparking 18 18
Overheating of Device 16 16
Protective Measures Problem 10 10
Therapeutic or Diagnostic Output Failure 10 10
Material Frayed 9 9
Use of Device Problem 9 9
Failure to Reset 7 7
Fire 6 6
Temperature Problem 5 5
Arcing 5 5
Communication or Transmission Problem 5 5
Display or Visual Feedback Problem 4 4
Output Problem 4 4
Melted 4 4
Calibration Problem 4 4
No Audible Alarm 4 4
Device Displays Incorrect Message 3 3
Mechanical Problem 3 3
No Apparent Adverse Event 3 3
Defective Device 3 3
Inflation Problem 3 3
Appropriate Term/Code Not Available 2 2
Increase in Pressure 2 2
Positioning Problem 2 2
Smoking 2 2
Break 2 2
Pressure Problem 2 2
Leak/Splash 2 2
Failure to Power Up 1 1
Battery Problem 1 1
Flare or Flash 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
Defective Component 1 1
Material Deformation 1 1
Device Emits Odor 1 1
Detachment of Device or Device Component 1 1
Device Sensing Problem 1 1
Electrical Shorting 1 1
Patient-Device Incompatibility 1 1
Material Puncture/Hole 1 1
Under-Sensing 1 1
Energy Output Problem 1 1
Electrical Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 81 81
Insufficient Information 26 26
Pressure Sores 23 23
No Known Impact Or Consequence To Patient 19 19
Thrombosis/Thrombus 9 9
No Patient Involvement 8 8
Electric Shock 6 6
Thrombosis 6 6
Nerve Damage 6 6
Hematoma 5 5
Burn(s) 5 5
Pain 5 5
No Consequences Or Impact To Patient 4 4
Stroke/CVA 3 3
Bruise/Contusion 3 3
Pulmonary Embolism 3 3
Impaired Healing 2 2
Hip Fracture 2 2
Skin Inflammation/ Irritation 2 2
Bone Fracture(s) 2 2
Embolism/Embolus 2 2
Hemorrhage/Bleeding 2 2
Injury 2 2
Hypervolemia 1 1
Ambulation Difficulties 1 1
Distress 1 1
Hypoesthesia 1 1
Inadequate Pain Relief 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Shaking/Tremors 1 1
Laceration(s) 1 1
Dyspnea 1 1
Loss of Range of Motion 1 1
Numbness 1 1
Discomfort 1 1
Rash 1 1
Cardiac Arrest 1 1
Skin Discoloration 1 1
Blister 1 1
Localized Skin Lesion 1 1
Ischemia 1 1
Sweating 1 1
Sleep Dysfunction 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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