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HSA / FSA / Health Insurance + FDA Information

Eczema Pajamas Clos-up Fabric Image

Soothems eczema clothing are made from high performance raw materials TENCEL® with Chitosan, TANBOOCEL® (viscose made from bamboo), and Creora® latex free spandex for treating atopic dermatitis/eczema with either dry or wet wrapping, and in combination with a healthcare professiona's recommendation for special eczema treatment bathes, or to cover eczema topical creams, lotions or emollients and moisturizers.

Soothems are registered with the FDA as a Class 1 Medical Deviceand could be eligible for medical insurance and health savings account claims. Please check with your individual health insurance provider and yoursubscriber's /member's benefit plan to determine eligibility.

Medical Insurance Information
Soothems are eligible, but cannot guarantee health insurance payment coverage, or that your HSA/FSA debit card will be accepted by our credit card processor as part of your Soothems purchase. You must refer to your subscriber's/member's contract benefits to determine if Soothems eczema clothing, that are registered with the FDA as a Class 1, Medical Device, are covered under your subscriber’s/member's benefit plan.

Please note that just because a service, procedure, device, or equipment that has been issued a CPT or HCPCS code and is approved by the FDA does not mean that the service procedure, device, or equipment is covered by your insurance. Each policy is different.

If this is a contingency requirement for your purchasing Soothems eczema clothing, please check with your individual health insurance provider prior to making a purchase.

Your insurance provider may require prior authorization or supporting documentation in order to process and cover a claim for the requested Soothems therapy. A patient-specific letter of necessity will help to explain the patient’s needs and the physician’s rationale and clinical decision in recommending Soothems. It may be helpful for the recommending physician to briefly describe dry or wet wrapping as a highly effective therapy used in the treatment of atopic eczema, and that it can involve the use of a cream, lotion, or emollient under Soothems which is acting as retention bandaging and that Soothems are made from special fibers that keep the skin hydrated and moist, control bacteria growth and help reduce skin inflammation thereby relieving itching.

The link below has a sample letter of medical necessity that can be customized by the medical care provider based on patient medical history and demographic information. Please note that some payers may have specific forms that must be completed to process payment or to document medical history.


HRA, HSA or Health Care FSA is enabled to accept payment from most major health insurance company HRA, HSA or Health Care FSA credit cards allowing you to reimburse yourself for medical expenses under Section 213(d) of the tax code as a federal income tax deduction. If your HRA, HSA, FSA card is declined at check-out please contact the issuing card company with questions. Other than providing the information above like the CPT / HCPCS code number and the FDA registration information, we are sorry, Soothems cannot help with the resolution of the payer’s decision, it is a matter between you and your subscriber’s /member’s benefit plan and the payer.

Federal Drug Administration Information
Soothems garments and our TEWLTect smart fabric are registered with the Federal Drug Administration as a Class 1, Medical Device, exempt status in the Durable Medical Equipment (DME) category 880.5075. Soothems FDA Registration Number is 3013841561and the Soothems FDA owner operator number is 10055549.

Soothems CPT / HCPCS code is A4467
The CPT (or Current Procedural Terminology) or HCPCS (Healthcare Common Procedure Coding System) is a medical code that is used to report medical, surgical, and diagnostic procedures and services to entities such as physicians, health insurance companies and accreditation organizations. A4467 is a valid 2018 CPT/HCPCS code for "belt, strap, sleeve, garment, or covering, any type" category for which Soothems has been classified under.


Size Charts

+ Soothems work best when worn tight fitting, but not restrictive.
+ Soothems are designed with a generous amount of stretch so they can fit close to the skin.
+ We recommend that if there is any doubt about size selection, the next larger size should be chosen provided it will still fit snugly.
+ Soothems are a personal healthcare medical device and therefore are not eligible for returns or exchanges once the poly bag seal has been broken 
+ or the poly bag has been opened and / or the product has been removed from the poly bag. If you have any questions regarding the fit of an item, please contact Soothems at or call +612.601.0700, we are happy to help.

Body Measurement

Relief Skull Cap

+ Using a soft tape, measure around the head just above the ears, across the forehead to determine circumference
+ TEWLTect smart fabric has a generous amount of stretch. 

Arm & Leg Sleeves

+ Using a soft tape, measure around the bicep for arm sleeve or mid-thigh to determine circumference
+ TEWLTect smart fabric has a generous amount of stretch
+ We recommend a snug fit so choose the smallest size closest to the child's bicep or mid-thigh circumference measurement
+ Sleeve shape tapers from widest circumference width to fit forearm or calf

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