Tortle Medical Division
Providing patients with the care they need and the attention they deserve.
FDA Advises Parents Not to Use Head Shaping Pillows While Tortle Beanies Stay Safe
On November 3, 2022, the U.S. Drug and Food Administration (FDA) issued a warning advising parents not to use infant head shaping pillows. Tortle Corrective Beanies, on the other hand, remain a safe and effective method for correcting infant head shapes.
Having been cleared and categorized by the FDA as a Class-I Medical Device—completely separate from head shaping pillows—the Tortle Lucky Elephant (available in Medium and Large sizes) is not classified as a hat, but a cap device—a different category, cleared by the FDA.
FDA-Cleared, Class-1 Medical Devices
Tortle medical devices provide unparalleled benefits to babies—premature, newborn, infant, or toddler—during that crucial period after birth, as well as throughout the difficult days of intensive care.
Support Until They're Happily Grown at Home
The Tortle Positioning System provides safe and precise head positioning for infants, from birth to six months adjusted age, in and out of the hospital. Tortle provides benefits for babies in various circumstances, situations, and environments, including outpatient care facilities and hospitals.
Providing Crucial, Consistent Care
Tortle provides doctors, nurses, respiratory and physical therapists, and other healthcare professionals with effective tools that promote consistency of care, as well as support and accessibility in dealing with sick and/or critical babies.
Additionally, Tortle medical devices help to support positioning protocols, prevent cranial asymmetry and head preference, and are extremely helpful in supporting neutral positioning, such as supine, midline, side-lying, and prone positions.