The CozeeCoo® Wearable Baby Blanket and Medical Device

The CozeeCoo® is a mobile-arms wearable infant positioning blanket and FDA-registered Class I medical device. Designed to position a baby's hands below the chest while allowing movement of the arms, elbows, hips, and body. Designed to help deter hand-to-face interference and to help deter removal of topical medications. Sized by arm span, not age. Sizes range from Newborn/Preemie through nominal 15 months. Because sizing is based on arm span, the 12–15 month size has fit children 16 months to 3 years. View the size chart → HSA, FSA, and HRA eligible with a Letter of Medical Necessity (LMN). Product Features (When Worn According to the Instructions for Use) Listed and registered with the U.S. Food and Drug Administration (FDA) as a Class I medical device. Independently third-party lab tested to meet the U.S. Consumer Product Safety Commission (CPSC) safety requirements. Holds a Children's Product Certificate (CPC). Designed to comfortably hold the hands below the chest while allowing movement of the limbs, elbows, hips, and body — including hand-to-hand touch inside the looped sleeve, grasping, sitting, flexion and extension of the limbs, reach, midline crossing, and bilateral coordination. Designed to be worn safely and comfortably in a standard car seat. Adjustable snap closures for fit adjustments and easy diaper changing. The caregiver can loop their arm through the tubed sleeve for two free hands while diaper changing. Open chest and legs to allow movement, breathability, and skin-to-skin contact. Designed for comfortable breastfeeding or bottle feeding for both caregiver and baby. Crafted from 100% certified organic cotton — main fabric, sew-in interfacing, and labels. Reversed stretch seams at the neck and shoulders to mitigate thread friction on the skin. Encased-thread French seam inside the looped sleeve to protect tiny fingernails. Hypoallergenic — free from nickel (a common allergen), toxic dyes or substances, bleach, formaldehyde, and fragrances. Naturally stretches with knitted interlocking loops. Washer, iron, and dryer safe when used according to care instructions. Designed For Designed to position hands below the chest. Designed to help deter hand-to-face interference. Designed to help deter removal of topical medications. Common Care Applications Situations where infants interfere with sensitive areas at or above the chest following pediatric surgical procedures (e.g., cleft lip and/or palate repair, cochlear hearing implants, cardiac surgery, jaw distraction surgery, cataract surgery, surgical excision). Situations where infants interfere with pediatric medical devices at or above the chest (e.g., cleft taping, NAM devices, feeding tubes, breathing tubes, hearing aid headbands, tracheostomy tubes, or monitoring lines). Situations involving frequent or repetitive hand-to-face interference (e.g. during skin discomfort related to severe eczema, allergies, hives). Situations where infants interfere with topical medications at or above the chest. Disclaimer: The CozeeCoo® is not a treatment or a cure. This is not a complete list of uses. Please consult with your child's healthcare provider to determine if CozeeCoo® is appropriate for your infant's care routine.