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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 2
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 3
GUANGDONG YOUMENG ELECTRICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
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
PHILIPS CONSUMER LIFESTYLE B.V.
  SUBSTANTIALLY EQUIVALENT 1
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 23
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 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 231 231
Suction Problem 80 80
Power Problem 39 39
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
Decrease in Suction 3 3
Fitting Problem 2 2
Sparking 2 2
Break 2 2
No Display/Image 2 2
Fire 2 2
Incomplete or Missing Packaging 2 2
Device Damaged Prior to Use 2 2
Defective Device 2 2
Material Integrity Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Failure to Power Up 2 2
Malposition of Device 1 1
Accessory Incompatible 1 1
Patient-Device Incompatibility 1 1
Unclear Information 1 1
Pumping Stopped 1 1
Flare or Flash 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Human-Device Interface Problem 1 1
Overheating of Device 1 1
Device Displays Incorrect Message 1 1
Loss of or Failure to Bond 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Breast Discomfort/Pain 242 242
Unspecified Infection 159 159
Inflammation 150 150
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
Swelling/ Edema 6 6
Unspecified Tissue Injury 6 6
Superficial (First Degree) Burn 5 5
Unspecified Reproductive System or Breast Problem 5 5
Skin Tears 5 5
Burn(s) 5 5
Abscess 4 4
Fungal Infection 3 3
Hemorrhage/Blood Loss/Bleeding 3 3
Skin Infection 2 2
Bruise/Contusion 2 2
Emotional Changes 2 2
Discomfort 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Rash 2 2
Fever 2 2
Blister 2 2
Sepsis 2 2
Hepatitis 1 1
Exposure to Body Fluids 1 1
Diarrhea 1 1
Autoimmune Disorder 1 1
Eye Irritation 1 1
Laceration(s) 1 1
Nasal congestion 1 1
Easy Bruising 1 1
Calcium Deposits/Calcification 1 1
Cognitive Changes 1 1
Abnormal mucus discharge 1 1
Itching Sensation 1 1
Abrasion 1 1
Headache 1 1
Infiltration into Tissue 1 1
Sore Throat 1 1
Eczema 1 1
Arthritis 1 1
Tissue Breakdown 1 1
Distress 1 1
Kidney Infection 1 1
Cyst(s) 1 1

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