| Device Type ID | 3959 |
| Device Name | Pump, Breast, Powered |
| Regulation Description | Powered Breast Pump. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.5160 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HGX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3959 |
| Device | Pump, Breast, Powered |
| Product Code | HGX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Breast Pump. |
| CFR Regulation Number | 884.5160 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARDO MEDICAL AG | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BISTOS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CIMILRE CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DAO HEALTH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEVON MEDICAL PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EXPLORAMED NC7, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GENADYNE BIOTECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GUANGZHOU JINXINBAO ELECTRONIC CO.,LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIMERICK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDELA | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MEDELA HOLDING AG | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
UNIMOM CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
UZINMEDICARE CO. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
WUXI XINZHONGRUI BABY SUPPLIES CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fluid Leak | 159 |
Suction Problem | 86 |
Device Operates Differently Than Expected | 30 |
Smoking | 29 |
Decrease In Suction | 23 |
Insufficient Information | 13 |
Sparking | 10 |
Inappropriate Shock | 9 |
Adverse Event Without Identified Device Or Use Problem | 8 |
Break | 5 |
Power Problem | 4 |
Fire | 3 |
Appropriate Term/Code Not Available | 3 |
Noise, Audible | 3 |
Housing | 3 |
Overheating Of Device | 2 |
Protective Measures Problem | 2 |
Increase In Suction | 2 |
Melted | 2 |
Wire | 2 |
Battery Problem | 2 |
Material Integrity Problem | 1 |
Device Inoperable | 1 |
Port | 1 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 1 |
Transformer | 1 |
Patient-Device Incompatibility | 1 |
Failure To Charge | 1 |
Obstruction Of Flow | 1 |
Device Handling Problem | 1 |
Plate | 1 |
Pump | 1 |
Complete Blockage | 1 |
Plug | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Detachment Of Device Or Device Component | 1 |
Failure To Shut Off | 1 |
Charred | 1 |
Crack | 1 |
| Total Device Problems | 418 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | AMEDA, INC. | III | Feb-15-2018 |
| 2 | Energizer Personal Care | II | Apr-04-2014 |