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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device blood pressure cuff
Regulation Description Blood pressure cuff.
Definition A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Product CodeDXQ
Regulation Number 870.1120
Device Class 2


Premarket Reviews
ManufacturerDecision
CARDICARE COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HONSUN(NANTONG)CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
JKH USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
LITTLE DOCTOR ELECTRONIC (NANTONG)CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI CAREMATE MEDICAL DEVICE CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CORERAY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MEDKE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN PLINMA TECHNOLOGY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SINO-K MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU MINHUA MEDICAL APPARATUS SUPPLIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU KANGSHUN MEDICAL DEVICES CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU LONGWAN MEDICAL DEVICE FACTORY
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU XIKANG MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU XIKANG MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUXI EXANOVO MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG LUDE TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 12 12
2022 3 3
2023 20 20
2024 15 15
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Unraveled Material 4 4
Pressure Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Material Separation 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Peeled/Delaminated 3 3
Unable to Obtain Readings 2 2
Patient-Device Incompatibility 2 2
Biocompatibility 2 2
Material Integrity Problem 2 2
Break 1 1
Gas/Air Leak 1 1
Electrical Power Problem 1 1
Low Readings 1 1
Insufficient Information 1 1
Material Deformation 1 1
Material Frayed 1 1
Material Discolored 1 1
Detachment of Device or Device Component 1 1
Device Sensing Problem 1 1
Air/Gas in Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
Insufficient Information 10 10
Pain 2 2
Rash 2 2
No Consequences Or Impact To Patient 2 2
Contact Dermatitis 2 2
No Known Impact Or Consequence To Patient 2 2
Caustic/Chemical Burns 2 2
Loss of Range of Motion 1 1
Skin Discoloration 1 1
Tachycardia 1 1
Muscle/Tendon Damage 1 1
Skin Infection 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Superficial (First Degree) Burn 1 1
Anaphylactic Shock 1 1
Cerebrospinal Fluid Leakage 1 1
Eye Injury 1 1
Myalgia 1 1
Viral Infection 1 1
Post Operative Wound Infection 1 1
Needle Stick/Puncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Medical Systems Information Technologies Inc II Jun-06-2024
2 ICU Medical, Inc. II May-01-2020
3 Volcano Corp II Jun-16-2022
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