Quality Assurance

Rest Assured with Tortle Quality Assurance

Inspected, checked, protected, checked again—Your baby receives only the highest quality of care when using Tortle Corrective Beanies. Learn more about what goes into FDA clearances, how Tortles are produced for safety, and more!

Production Sizing

Our efforts to ensure parents only receive the size they order begins well, at the very beginning! We go so far as to make sure manufacturing/production runs of sizes are separated by eight months. This is to prevent, for instance, medium-sized Tortle Beanies from being mixed in with large-sized Beanies. That way, you get the correct product and your baby gets the corrective device they need to fight Flat Head Syndrome head on. 

It's extremely rare that customers receive a Tortle Beanie in a size other than what was ordered. However, if you do need to return your unopened Tortle product, you can do so as long as you contact Tortle within five (5) business days of receiving it.

Made in the Best Facilities

Not all manufacturing facilities are made equal. Here at Tortle, we dedicated ourselves to identifying the best possible production facilities to handle our designs, resulting in the best possible products and outcomes for your baby. We take pride in knowing that all Tortle Beanies are produced in safe and clean environments with close attention to detail. What else do we do to ensure you and your baby receive the best?

In-person, on-site inspections of plants for health and safety.

Separate sizing and material production runs.

Ongoing quality checks on raw materials. 

QA protocols for products received from facilities, prior to customer shipments.

What It Means to Be FDA-Cleared

Tortle is much more than a beanie, it’s actually an FDA-cleared medical device providing your baby with constant care for healthy head and neck development. But what does it mean for a medical device like the Tortle Lucky Elephant or Tortle Air to both be cleared by the U.S. Food and Drug Administration?

FDA clearance is granted to medical devices that compare to an already existing, legally marketed device, and that can demonstrate the same level of safety and effectiveness as that device. In order to become FDA-cleared, companies must submit a 510(k) for product review and clearance

Tortle has taken and continues to take every step and precaution necessary to assure our pediatric medical devices’ quality and safety, so your baby and you can rest peacefully. 

Print Your Perfect Fit

Providing the perfect fit for your baby's head is essential to the effectiveness and quality of care your Tortle produces. Tortle Beanies are designated as single-patient, multiple-use devices. And, as an FDA-cleared medical device, once returned we cannot reuse or re-sell the product in any capacity for fear of passing on infection. 

To keep babies safe and reduce waste, we strongly encourage our Tortle parents to download and print our perfect fit guide. Use the measuring tape below to size your baby’s head and make the correct Tortle Beanie purchase!

Print Tortle Fit Guide

Don’t Fret the Fuss

When you first place a Tortle on your baby, he or she may fuss and appear as if they don’t like it. This is natural, especially if your baby is not used to wearing a hat. The Tortle may also cause them to fuss because it’s preventing them from resting their head in the position they prefer, which has caused the flat spot or Torticollis in the first place. 

Most babies adjust quickly (within a few days) to their new head position and adapt well to your repositioning practices.

View Repositioning Techniques