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 Type ID | 4099 |
Device Name | Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure |
Physical State | External Device That Provides Positive Pressure To A Woman’s Breast. |
Technical Method | Provide Low, Positive Pressure To The Breast To Aid In Expression Of Milk In Conjunction With A Powered Or Non-powered Breast Pump. |
Target Area | Breast |
Regulation Description | Nonpowered 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) Exempt |
CFR Regulation Number | 884.5150 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | PWA |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4099 |
Device | Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure |
Product Code | PWA |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Nonpowered Breast Pump. |
CFR Regulation Number | 884.5150 [🔎] |