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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 2
AIROS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
APEX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
B & J MANUFACTURING LTD
  SUBSTANTIALLY EQUIVALENT 1
B & J MANUFACTURING LTD.
  SUBSTANTIALLY EQUIVALENT 2
B&J MANUFACTURING LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIO COMPRESSION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH200, LLC
  SUBSTANTIALLY EQUIVALENT 1
DAESUNG MAREF CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
DAESUNG MAREF CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 1
MANAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDHEALTH MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDI USA, L.P.
  SUBSTANTIALLY EQUIVALENT 1
MEGO AFEK AC LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO8 INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHO8, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
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 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 28 28
Insufficient Information 27 27
Overheating of Device 16 16
Sparking 15 15
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
Calibration Problem 4 4
No Audible Alarm 4 4
Device Displays Incorrect Message 3 3
No Apparent Adverse Event 3 3
Defective Device 3 3
Appropriate Term/Code Not Available 2 2
Increase in Pressure 2 2
Inflation Problem 2 2
Positioning Problem 2 2
Smoking 2 2
Mechanical Problem 2 2
Break 2 2
Pressure Problem 2 2
Leak/Splash 2 2
Failure to Deliver 1 1
Battery Problem 1 1
Failure to Power Up 1 1
Flare or Flash 1 1
Gas/Air Leak 1 1
Structural Problem 1 1
Defective Component 1 1
Audible Prompt/Feedback Problem 1 1
Lack of Effect 1 1
False Alarm 1 1
Patient-Device Incompatibility 1 1
Device Emits Odor 1 1
Material Puncture/Hole 1 1
Detachment of Device or Device Component 1 1
Device Sensing Problem 1 1
Electrical Shorting 1 1
Energy Output Problem 1 1
Electrical Power Problem 1 1
Under-Sensing 1 1
Device Markings/Labelling Problem 1 1
Incomplete or Inadequate Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 76 76
Insufficient Information 26 26
Pressure Sores 22 22
No Known Impact Or Consequence To Patient 19 19
No Patient Involvement 8 8
Thrombosis/Thrombus 8 8
Thrombosis 6 6
Electric Shock 5 5
Nerve Damage 5 5
No Consequences Or Impact To Patient 4 4
Pain 4 4
Burn(s) 4 4
Bruise/Contusion 3 3
Pulmonary Embolism 3 3
Stroke/CVA 3 3
Hemorrhage/Bleeding 2 2
Injury 2 2
Hematoma 2 2
Bone Fracture(s) 2 2
Skin Inflammation/ Irritation 2 2
Hip Fracture 2 2
Impaired Healing 2 2
Rash 1 1
Skin Discoloration 1 1
Localized Skin Lesion 1 1
Blister 1 1
Loss of Range of Motion 1 1
Embolism/Embolus 1 1
Discomfort 1 1
Numbness 1 1
Ischemia 1 1
Dyspnea 1 1
Laceration(s) 1 1
Shaking/Tremors 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Sweating 1 1
Hypoesthesia 1 1
Inadequate Pain Relief 1 1
Sleep Dysfunction 1 1
Distress 1 1
Ambulation Difficulties 1 1
Hypervolemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho8, Inc. II Aug-19-2021
2 Stryker Sustainability Solutions II May-19-2023
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