510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PWAClass I

Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure

21 CFR 884.5150 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

PWA is the FDA product code for Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure, a class I device type, regulated under 21 CFR 884.5150. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PWA
Device name
Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure
FDA 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.
Regulation
21 CFR 884.5150
Device class
Class I
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order