# K150139: Rachel's Remedy

- Pathway: 510(k) (Traditional)
- Applicant: Rachel'S Remedies, LLC
- Decided: May 22, 2015 after 120 days
- Product code: IMA (Pack, Heat, Moist)
- Device class: 1
- Regulation: 21 CFR 890.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K832803 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832803: Steam Pak Moist Heat, Electro-Med Health Industries, Inc. (1983) Summary page 5.
- K841698: Heat Pack, Maddak, Inc. (1984) Summary page 5.

## Indications for use
Rachel's Remedy is designed to provide moist heat and/or cooling relief to relieve symptoms associated with clogged ducts, mastitis, milk blisters, blebs and engorgement. It is also designed to encourage let-down and milk flow, and can help prevent mastitis.

Source page: https://510kreport.com/device/K150139
Methodology: https://510kreport.com/methodology