Binder, Breast
The Breast Binder is a supportive garment or wrap used to apply compression to the breast tissue, typically following surgery, for engorgement management, or to suppress lactation. It is classified as FDA Class 1 (lowest risk) within the General Hospital specialty, subject only to general controls, and is exempt from 510(k) premarket notification. The product code is HEF, regulated under 21 CFR 880.5160. This device is GMP exempt, meaning it is also exempt from full Good Manufacturing Practice quality system requirements.
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Basic Information
- Product Code
- HEF
- Device Class
- FDA class 1
- Regulation Number
- 880.5160
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 45 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 45 registration numbers. Click on an entry to view related FDA registrations.