SAFEY is always our first priority. We never compromise safety for anything else.

WowieStar is proudly made of USA FDA certified class USP VI medical-grade silicone – the safest rated silicone, implantable in human body for up to 28 days and designed for healthcare and human body contact applications. The color is part of material and meets safety standard as well.

The material has passed the following tests:

  • Systemic Injection Test
  • Intracutaneous Toxicity Test 
  • Intramuscular Implantation Test
  • Agar Diffusion Test
  • MEM Elution Test 
  • Hemolysis – Rabbit Blood 
  • Ames Test
  • Kilgman Maximization Test
  • Systemic Injection Test

It is also BPA free, phthalate free and latex free, as well as freezer, dishwasher and boiling-water safe (-40F to +248F / -40C to +120C). This material does not stiffen or deform after being placed in the freezer.

Our Partners

We spent 1 year interviewing, comparing and selecting partners to meet our standards.

We are proud to share with you that WowieStar is designed, produced and packaged 100% in USA.

Our USA-based manufacturing partner also sources material from a leading US company, and the manufacturing process is ISO 10993 certified and audited annually by the FDA.

Our packaging is also made in the USA from eco-friendly green, frustration-free and fully recyclable materials.

Finally, we manually inspect hand-polish and package each WowieStar in our Seattle base so that it gets to your baby in pristine condition.