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510(k) Data Aggregation
K Number
K150139Device Name
Rachel's Remedy
Manufacturer
Rachel's Remedies, LLC
Date Cleared
2015-05-22
(120 days)
Product Code
IMA, IMD
Regulation Number
890.5730Why did this record match?
Product Code :
IMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
Rachel's Remedy is a hot/cold therapy pack composed of a 100% cotton flannel pillow filled with all natural flaxseed. It is designed to provide heating or cooling relief to soothe breastfeeding pain and discomfort. The pillow is inserted into a food-safe water-resistant pouch. There is a removable 100% organic cotton layer that may be moistened and used for moist heat, or the therapy pack may be used alone for heating and/or cooling relief. The flaxseed filled pillow can either be microwaved for heating relief, or put in the freezer for cooling relief.
Rachel's Remedy is made from materials manufactured in the United States. The removable cotton layer is 100% organic cotton, the pouch is CPSIA certified and foodsafe PUL, and the flaxseed filled pillow is made from 100% cotton flannel and is filled with 100% all natural flaxseed. All of the fabrics used in Rachel's Remedy are made in the United States and are CPSIA certified and made specifically for baby products.
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