Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure

PWA · Class I — Low Risk (general controls) · Obstetrics/Gynecology · 21 CFR 884.5150

Classification

FDA Product Code: PWA
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 884.5150
Review panel: OB
Medical specialty: Obstetrics/Gynecology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 23

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown