In partnership with Phoenix Society
for Burn Survivors, the First and Only
Therapeutic Bedding

Frequently Asked Questions

What does FDA clearance mean?

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)

What sort of testing has been done for skin sensitivity?

Lifeloom's DermaTherapy® fabric technology has been tested many times for skin sensitivity as it may relate to concerns from those suffering with psoriasis and eczema. These tests included analyses of skin irritation, skin sensitization, and cytotoxicity. In all such testing, the fabric showed passing results, with no cytotoxicity or sensitivity for at-risk skin. The FDA reviewed test results and found them to pass standards for medical devices used in contact with the skin.

* 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

What is the fabric made of?

Lifeloom’s bedding is crafted from DermaTherapy® fabric technology, and is woven from a blend of polyester and nylon yarns.

Where is Lifeloom bedding made?

Our FDA-cleared bedding is made in the United States.

What does “moisture-wicking” mean?

The DermaTherapy® fabric technology is crafted from woven fibers with unique cross sections that create micro-channels. These micro-channels carry–or “wick”–moisture away from skin, keeping your skin fresh and pores clean.

What is Lifeloom’s return policy?

All Lifeloom bedding made with DermaTherapy® fabric technology meet the strictest standards of quality as defined by our stringent ISO 9001 certification. You can expect to realize the mitigating benefits of our bedding within 2–3 weeks. Should you become dissatisfied with your purchase for any reason, Lifeloom will accept a return within 90 days of date-of-purchase. Customer is responsible for return shipping, and returns will be refunded in the original method of payment. It is recommended to use a tracking number when returning product.

Is there a product warranty?

All linens crafted using DermaTherapy® technology include a one-year warranty against manufacturer defects.