Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure

Device Code: 4099

Product Code(s): PWA

Definition: Designed To Be Used In Conjunction With Powered Or Non-powered Breast Pumps To Apply Positive Pressure To The Breast To Aid In Milk Expression From The Breasts Of A Nursing Woman.

Device Classification Information

Device Type ID4099
Device NameBreast Pump Accessory, Milk Expression Aid, Via Positive Pressure
Physical StateExternal Device That Provides Positive Pressure To A Woman’s Breast.
Technical MethodProvide Low, Positive Pressure To The Breast To Aid In Expression Of Milk In Conjunction With A Powered Or Non-powered Breast Pump.
Target AreaBreast
Regulation DescriptionNonpowered Breast Pump.
Regulation Medical SpecialtyObstetrics/Gynecology
Review PanelObstetrics/Gynecology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Obstetrics And Gynecology Devices Branch (OGDB)
Submission Type510(K) Exempt
CFR Regulation Number884.5150 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodePWA
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4099
DeviceBreast Pump Accessory, Milk Expression Aid, Via Positive Pressure
Product CodePWA
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNonpowered Breast Pump.
CFR Regulation Number884.5150 [🔎]
TPLC Last Update: 2019-04-02 20:42:59

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