FDA Approved for the Treatment of Pressure Injuries

DermaTherapy® Sheets with FDA Cleared icon

DermaTherapy® therapeutic linen is an FDA cleared, evidence-based solution that is proven to deliver positive outcomes.

FDA 510(k) Clearance No. K152884. Indications for Use: Bed linens made with DermaTherapy® fabrics are intended for use by patients 18 years of age and older in hospital settings who are susceptible to pressure ulcers. The DermaTherapy® Bed Linens help to reduce the likelihood of patients developing pressure ulcers by reducing moisture, friction and shear on the patient’s skin. Visit FDA.gov for more information

FDA 510(k) Clearance No. K061242. Indications for Use: Institutional Bedding (bed sheets and pillow cases) made with DermaTherapy® fabrics is intended for use by patients in a hospital, healthcare or home setting who are susceptible to or may have mild atopic dermatitis. Visit FDA.gov for more information

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