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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, breast, powered
Regulation Description Powered breast pump.
Product CodeHGX
Regulation Number 884.5160
Device Class 2


Premarket Reviews
ManufacturerDecision
AMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANKER INNOVATIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ANNABELLA , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANNABELLA TECH
  SUBSTANTIALLY EQUIVALENT 1
AOJ HEALTH TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARDO MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
BISTOS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CHIARO TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CHIARO TECHNOLOGY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CIMILRE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CIXI RUIHONG ELECTRIC APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN RONGFENG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUANSHI YIYINGMEI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVENFLO FEEDING, INC.
  SUBSTANTIALLY EQUIVALENT 1
FIMILLA (SHANGHAI) MATERNITY & BABY ARTICLES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG YOUMENG ELECTRICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
GUANGZHOU YONGYI INDUSTRIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAENIM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU LVB MATERNAL AND INFANT SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
HYGEIA II MEDICAL GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMANI CO.
  SUBSTANTIALLY EQUIVALENT 3
JIANGXI AOV MATERNITY & BABY PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOYTECH HEALTHCARE CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
LANSINOH LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
LINHEJIACHENG (SHENZHEN) E-COMMERCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAYBORN (UK) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDELA AG
  SUBSTANTIALLY EQUIVALENT 1
MEDELA, LLC
  SUBSTANTIALLY EQUIVALENT 4
MILKMATE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NINGBO DEAREVERY ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHANTOU HUIHENGQI ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LUTEJIACHENG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN TPH TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 18
SHENZHEN ROOT INNOVATION TECHNOLOGY CO., , LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNIMOM.CO
  SUBSTANTIALLY EQUIVALENT 2
UZINMEDICARE CO.
  SUBSTANTIALLY EQUIVALENT 1
UZINMEDICARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
WILLOW INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
WUXI XINZHONGRUI BABY SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
X6 INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG CAREBAO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 119 119
2022 154 156
2023 200 201
2024 118 118
2025 70 70
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 233 233
Suction Problem 113 114
Decrease in Suction 94 94
Power Problem 35 35
Adverse Event Without Identified Device or Use Problem 33 33
Failure to Power Up 16 16
Insufficient Information 14 14
Suction Failure 11 11
Noise, Audible 10 10
Unexpected Shutdown 10 10
Output Problem 9 9
Break 8 8
Therapeutic or Diagnostic Output Failure 7 7
Defective Device 7 9
Fire 6 6
Obstruction of Flow 6 6
Increase in Suction 5 5
Product Quality Problem 5 6
Overheating of Device 4 4
Charging Problem 4 4
Patient-Device Incompatibility 4 4
Inadequacy of Device Shape and/or Size 3 3
Defective Component 3 3
Energy Output Problem 3 3
Pumping Problem 3 3
Fitting Problem 3 3
Vibration 2 2
Fluid/Blood Leak 2 3
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Contamination 2 2
Microbial Contamination of Device 2 2
Improper or Incorrect Procedure or Method 2 2
Loose or Intermittent Connection 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Device Damaged Prior to Use 2 2
Use of Device Problem 2 2
Device Contamination with Body Fluid 2 2
Incomplete or Missing Packaging 2 2
Mechanical Problem 2 2
Sparking 2 2
Device Emits Odor 2 2
No Display/Image 2 2
Pressure Problem 2 2
Circuit Failure 1 1
Unintended Collision 1 1
Loss of or Failure to Bond 1 1
Device Displays Incorrect Message 1 1
Electrical /Electronic Property Problem 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Breast Discomfort/Pain 240 240
Unspecified Infection 159 159
Inflammation 131 131
Bacterial Infection 33 33
No Clinical Signs, Symptoms or Conditions 33 36
Insufficient Information 29 29
Pain 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Unspecified Tissue Injury 6 6
Swelling/ Edema 6 6
Obstruction/Occlusion 6 6
Skin Tears 5 5
Unspecified Reproductive System or Breast Problem 5 5
Superficial (First Degree) Burn 5 5
Burn(s) 5 5
Abscess 4 4
Fungal Infection 3 3
Discomfort 2 2
Bruise/Contusion 2 2
Emotional Changes 2 2
Fever 2 2
Hemorrhage/Bleeding 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Blister 2 2
Skin Infection 2 2
Rash 2 2
Sepsis 2 2
Distress 1 1
Cognitive Changes 1 1
Tissue Breakdown 1 1
Skin Inflammation/ Irritation 1 1
Eczema 1 1
Easy Bruising 1 1
Wheezing 1 1
Kidney Infection 1 1
Hepatitis 1 1
Headache 1 1
Itching Sensation 1 1
Infiltration into Tissue 1 1
Abrasion 1 1
Calcium Deposits/Calcification 1 1
Diarrhea 1 1
Arthritis 1 1
Autoimmune Disorder 1 1
Exposure to Body Fluids 1 1
Sore Throat 1 1

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