FDA designates PureCare’s Celliant as medical device, general wellness product
September 12, 2017,
FAIRFIELD, N.J. — PureCare, a leader in health and wellness bedding, received a push for its Celliant performance fiber products when the U. S. Food and Drug Administration (FDA) determined that Hologenix’ Celliant fibers, containing infrared emitting ceramic particles, are regulated as both “medical devices” and as ” general wellness products.”
With that designation, products that incorporate Celliant performance fibers are able to legally claim that the fibers promote increased localized blood flow, thereby increasing energy, boosting performance and speeding muscle recovery.
“When I bought into [PureCare] in 2009, we wanted to make our protectors more than the standard stain and warranty protector for the bed,” said PureCare President and COO Jeff Bergman. “We have been working with Celliant now for seven years and have really mastered how to incorporate the technical textile into our products.
As a result, working in a close relationship with Hologenix, in 2010 PureCare became the first company to offer mattress protectors with Celliant.
“When we decided to go into the sheet business, it was important to create sheets and pillow cases that utilized this fascinating technology to its best potential, while incorporating the key elements of what makes a sheet great,” said Bergman.
Chief Marketing Officer Sean Bergman said, “Performance is a want, but wellness is a need. … Celliant fibers are providing the best performance technology in bedding today.”
PureCare’s Celliant performance fiber features are offered in three different product categories.
• PureCare Celliant 5-Sided Mattress and Pillow Protectors offer not only premium protection from allergens, dust mites and mold and mildew, but also clinically tested recovery benefits from Celliant performance fibers.
• PureCare Elements Lumen Celliant Sheet Sets is the first premium linen collection with a superb fit, feel and finish to feature Celliant performance fibers, the company said.
• A collection of nine different PureCare Body Chemistry Pillows featuring Celliant includes latex, memory foam, down, down alternative, and the exclusive, patent-pending SoftCell and SoftCell Select pillow options.
“This FDA designation helps our retailers and our consumers understand the true benefits of Celliant performance fibers,” said Bergman.
PureCare will be showing its line of essential sleep products at High Point Market in the International Home Furnishings Center, M-531.
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