DermaTherapy has FDA clearance as a Class I medical device for atopic dermatitis, eczema and psoriasis, and pressure sores. DermaTherapy is the first and only bedding to achieve this distinction. Technical indications for use of DermaTherapy include:
* Class I medical device for use by people in hospital, healthcare or home settings who are susceptible to or may have atopic dermatitis, the most common form of eczema. (Reg. K061242)
* Class I medical device for use by patients who are susceptible to pressure ulcers. DermaTherapy Bed Linens help to reduce the likelihood of patients developing pressure ulcers by reducing moisture, friction and shear on the patient’s skin. (Reg. K152884)
We have had the fabric and bedding tested numerous times for skin sensitivity as it may relate to concerns from psoriasis/eczema sufferers. These tests included analyses of skin irritation, skin sensitization, and cytotoxicity. In all such testing, DermaTherapy showed passing results, with no cytotoxicity or sensitivity for at-risk skin. The FDA reviewed our test results and found them to pass standards for medical devices used in contact with the skin. In fact, the FDA cleared DermaTherapy as a Class I Medical Device for use by people suffering from psoriasis, eczema and atopic dermatitis.
* Standard No. ISO 10993-5, “Biological Assessment of Medical Products, Part 5: Tests for Cytotoxicity – MEM Elution; Version 10993-5”, Standard Date 01/01/1999
* Standard No. ISO 10993-10, “Biological Evaluation of Medical Devices – Part 10: Irritation: Intracutaneous Reactivity; Version 10993-10:2002(E)”, Standard Date 01/01/2002
* Standard No. ISO 10993-10, “Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Sensitization – Maximum Sensitization Test; Version10993-10:2002(E)”, Standard Date 01/01/2002
DermaTherapy fabrics are woven from a blend of polyester and nylon yarns.
DermaTherapy fabrics are woven from a strong, continuous-filament yarn that creates a consistently smooth, silk-like surface. Our fabrics are lint free, and release almost no lint or contaminating particles that can irritate the skin and infiltrate pores. Friction and skin abrasiveness are virtually eliminated.