Press Release- Crescent Womb has partnered with Acknowledge Regulatory Services in January 2021 to submit a 510(k) filing to the Food and Drug Administration (FDA) to register Crescent Womb products as a Class 1 Medical Device.

FOR IMMEDIATE RELEASE

Contact: James Spencer hello@crescentwomb.com

PINELLAS COUNTY, FLORIDA- July 1st 2021

Crescent Womb has partnered with Acknowledge Regulatory Services in January 2021 to submit a 510(k) filing to the Food and Drug Administration (FDA) to register Crescent Womb products as a Class 1 Medical Device. As of July 1st 2021, the group has submitted all initial filing documents. The principal lead on this project is the founder of Acknowledge Regulatory services, Allison C. Komiyama, Ph.D., R.A.C. Allison is a former FDA reviewer who received her Ph.D. in Neuroscience from Stanford University and her B.A. in Molecular and Cell Biology from University of California, Berkeley. In partnership with Dr. Komiyama, Crescent Womb has identified initial indicators for treatment of plagiocephaly (known as flat head syndrome) with the breakthrough device that is Crescent Womb™ Infant Safety Bed. Besides the obvious cosmetic issues associated with the disorder, several studies have also now reported associations between PPB and mental developmental delays, making means for prevention for important than ever before.

About Crescent Womb

Crescent Womb is pioneering innovations for early childhood health and safety. They are committed to accessible solutions to common problems for all families Crescent Womb’s message and products are a catalyst to change the conversation around the difficult topics of co-sleeping, SIDS, and overall quality of life.

About Acknowledge Regulatory Services

Acknowledge Regulatory Strategies specializes in Regulatory Affairs (RA) consulting exclusively for the medical device industry.

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