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 [🔎] |