Tumzee Tummy Time Tool Granted Class 1 Medical Device Status by FDA

New product status sparks interest for FSA, HSA and HRA account holders
pNeo LLC Logo
pNeo LLC Logo
DENTON, Texas - Feb. 27, 2019 - PRLog -- Business investor and incubator pNeo LLC today announced that its award-winning tummy time tool, Tumzee, has been classified as a Class 1 Medical Device by the Food and Drug Administration (FDA). Under this stringent, quality-controlled classification, wholesalers, distributors and end users have the assurance that Tumzee complies fully with FDA standards and regulatory control for proper branding and labeling, and a high standard of manufacturing and quality.

Co-Founder and Executive Officer, Charlotte Wenham stated: "We are extremely proud that Tumzee has been recognized for its quality and therapeutic benefits by the FDA. Tumzee is the fourth of our products to gain this distinction. We feel it confirms Tumzee as a best-in-class product. It's very rewarding to achieve such a high bar in this product category." Tumzee securely positions baby at an optimal incline to encourage hand/eye coordination and muscle development in the head, neck, shoulders, arms and core. Other pNeo innovations that meet the exacting Class 1 Medical Device standards of the FDA include CLEARinse, Oto-Tip, and Baby Shusher.

In addition, by merit of being classified as a medical device, Tumzee may now qualify for payment using pre-tax dollars accumulated in any flexible savings account (FSA), health savings account (HSA) or health reimbursement arrangement (HRA). This represents significant savings to customers, where eligible.


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Charlotte Wenham
Executive Director
Email:***@pneo.org Email Verified
Tags:Baby Products, Healthcare
Location:Denton - Texas - United States
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Page Updated Last on: Feb 27, 2019
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