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FDA determines BioPosture products with Celliant® are “medical devices” and “wellness products”

RV Winkle, LLC, owner of the BioPosture™ brand, announced today that all BioPosture products made with Celliant® (Mattresses, BedToppers, Pillows, and BioRepair Pain Management Compression Bands) have been determined to be "medical devices" and "general wellness products" as defined in Section 201(h) of the Federal Food, Drug and Cosmetics Act.

In a License Agreement with Hologenix, LLC, Santa Monica, CA, the developer and patent holder of Celliant, RV Winkle has been awarded exclusivity in providing its' Celliant® products to and through US Licensed Healthcare Providers.

BioPosture products with Celliant's infrared energy supports a temporary increase in local blood flow. This supports more restful sleep and a quicker recovery. The results of using Celliant® on and in our products has been very positive based on doctor and patient feedback", according to Thomas Jay Williams, President and CEO of BioPosture.

BioPosture products help active people recover faster, help increase endurance and energy as well as promoting restful sleep, among other benefits. Through counsel, RV Winkle is investigating the possibility that this FDA determination might facilitate at least partial insurance reimbursement for patients purchasing BioPosture products through their Healthcare Provider

BioPosture products are marketed exclusively through licensed healthcare providers who in concert with BioPosture strive to make the sleep environment healthier for their patients. In this regard, and because BioPosture makes each mattress on order, doctors can provide a Letter Of Medical Necessity, that permits the manufacture of BioPosture mattresses without the mandated fire retardant, for reduced chemical exposure.

For more information, contact:

Thomas Jay Williams