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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
A CUTE BABY, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANKER INNOVATIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
ANNABELLA , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANNABELLA TECH
  SUBSTANTIALLY EQUIVALENT 1
AOJ HEALTH TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARDO MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
AVITA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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 2
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 4
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 2
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 5
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
POLYBELL (GUANGZHOU) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SHANTOU HUIHENGQI ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN LUTEJIACHENG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN QINYI ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 10
SHENZHEN TPH TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 21
SHENZHEN ROOT INNOVATION TECHNOLOGY CO., , LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNIMOM.CO
  SUBSTANTIALLY EQUIVALENT 2
UZINMEDICARE CO.
  SUBSTANTIALLY EQUIVALENT 1
UZINMEDICARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
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 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 231 231
Suction Problem 75 75
Power Problem 35 35
Adverse Event Without Identified Device or Use Problem 15 15
Insufficient Device Problem Information 14 14
Suction Failure 4 4
Use of Device Problem 3 3
Failure to Power Up 2 2
Break 2 2
Decrease in Suction 2 2
No Display/Image 2 2
Fire 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Material Integrity Problem 2 2
Fitting Problem 2 2
Device Damaged Prior to Use 2 2
Incomplete or Missing Packaging 2 2
Defective Device 2 2
Sparking 2 2
Overheating of Device 1 1
Pumping Stopped 1 1
Accessory Incompatible 1 1
Loss of or Failure to Bond 1 1
Fluid/Blood Leak 1 1
Unclear Information 1 1
Patient-Device Incompatibility 1 1
Flare or Flash 1 1
Human-Device Interface Problem 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Breast Discomfort/Pain 241 241
Unspecified Infection 159 159
Inflammation 140 140
Bacterial Infection 33 33
No Clinical Signs, Symptoms or Conditions 33 36
Insufficient Information 29 29
Pain 16 16
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 12 12
Breast Feeding Problem 9 9
Obstruction/Occlusion 6 6
Unspecified Tissue Injury 6 6
Swelling/ Edema 6 6
Superficial (First Degree) Burn 5 5
Skin Tears 5 5
Burn(s) 5 5
Unspecified Reproductive System or Breast Problem 5 5
Abscess 4 4
Hemorrhage/Blood Loss/Bleeding 3 3
Fungal Infection 3 3
Sepsis 2 2
Bruise/Contusion 2 2
Skin Infection 2 2
Discomfort 2 2
Emotional Changes 2 2
Rash 2 2
Blister 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Fever 2 2
Cyst(s) 1 1
Eczema 1 1
Eye Irritation 1 1
Kidney Infection 1 1
Abnormal mucus discharge 1 1
Skin Inflammation/ Irritation 1 1
Infiltration into Tissue 1 1
Hepatitis 1 1
Abrasion 1 1
Easy Bruising 1 1
Exposure to Body Fluids 1 1
Distress 1 1
Arthritis 1 1
Calcium Deposits/Calcification 1 1
Laceration(s) 1 1
Itching Sensation 1 1
Autoimmune Disorder 1 1
Cognitive Changes 1 1
Sore Throat 1 1
Diarrhea 1 1
Wheezing 1 1
Headache 1 1

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