Why This Matters

• 100M+ Americans use HSA or FSA accounts

• Over $100B in tax-advantaged healthcare spending annually

• Many consumers actively search for FSA and HSA eligible expenses that support essential, medically necessary products

What Is HSA/FSA?

• Health Savings Account (HSA): Pre-tax savings for medical expenses. Individual-owned. Portable.

• Flexible Spending Account (FSA): Employer-sponsored, pre-tax savings. 'Use it or lose it' annually.

• Both require the expense to qualify under IRS Section 213(d)

How Steadi-3 Qualifies

The Steadi-3 anti-tremor glove is an FDA-registered Class I medical device designed to reduce hand tremors associated with Essential Tremor and Parkinson’s Disease. Because it is used to support daily function and mitigate symptoms, it qualifies as a reimbursable medical expense with a Letter of Medical Necessity for FSA or a Letter of Medical Necessity for HSA submission.

FSA vs HSA — Key Differences for Medical Device Reimbursement

Understanding the difference between a Flexible Spending Account (FSA) and a Health Savings Account (HSA) can help clarify how each account may be used for eligible medical device purchases, such as the Steadi-3 anti-tremor glove.

Both account types generally allow the use of pre-tax dollars for qualified medical expenses as defined under IRS Section 213(d), subject to individual plan rules and administrator approval.

Flexible Spending Account (FSA)

• Employer-sponsored benefit

• Contributions are made with pre-tax income

• Funds typically follow a use-it-or-lose-it policy within the plan year

• Some plans offer limited rollover or grace periods

• Often requires reimbursement after purchase
  

FSAs are commonly used for predictable healthcare expenses within a calendar year.

Health Savings Account (HSA)

• Available to individuals enrolled in a High-Deductible Health Plan (HDHP)

• Contributions are made with pre-tax income

• Funds roll over year to year with no expiration

• An account is portable if you change employers

• Can be used at the point of purchase or reimbursed later

HSAs generally offer more long-term flexibility, especially for higher-cost medical devices.

Key Similarity

Both FSAs and HSAs allow tax-free payment or reimbursement for qualified medical expenses, including certain FDA-registered medical devices when deemed medically necessary by a healthcare provider.

Using FSA or HSA Funds for Steadi-3 Purchases

With a Letter of Medical Necessity from a healthcare provider, the Steadi-3 glove may be eligible for FSA or HSA reimbursement, depending on the specific requirements and approval criteria of the individual plan administrator. An HSA may offer added flexibility since funds do not expire annually, but either account type can support reimbursement when plan requirements are met.

Contribution Limits

The IRS sets annual contribution limits for FSAs and HSAs, and these limits may change each year. You can confirm your current limits with your plan administrator or healthcare benefits provider.

Reimbursement Pathway

• Obtain a Letter of Medical Necessity for FSA from a healthcare provider.

• Purchase the Steadi-3 and retain your invoice.

• Submit the LMN + invoice to your administrator for approval as part of your FSA and HSA eligible expenses.

Digital Enablement Strategy

• Add LMN & receipt templates to post-purchase flow

• Website integration under the FAQ and product page

• Checkout flag: 'I plan to use HSA/FSA.

Strategic Partnerships

Steadiwear is preparing for marketplace placement on platforms like FSAstore.com and HSAstore.com to increase reach, consumer confidence, and discoverability among shoppers looking for medical devices covered as FSA and HSA eligible expenses.

Supporting Materials Ready

LMN Template (PDF) - https://app.box.com/s/wl0rdbzy1tujbtkt6b60bio7oma4mzst

Reimbursement Receipt & Website Copy

Template - https://app.box.com/s/ln7gf3wnnhna8t0exo8q91y6z48qt3zf

Internal FAQ for Support – Try to find another website that offers the FAQ for this matter and copy it without plagiarizing 

FDA ID: https://app.box.com/s/t8cm5gnwu7ftawlhsmatl35rcu6ptv6v

Let's Unlock Access

• Enable a new revenue channel by making Steadi-3 accessible to 100M+ Americans with pre-tax health savings.

• Contact: support@steadiwear.com | www.steadiwear.com

FAQ

Is Steadi-3 considered a Durable Medical Equipment (DME) for FSA/HSA purposes?

Steadi-3 is an FDA-registered Class I medical device designed to help mitigate hand tremors associated with diagnosed medical conditions such as Essential Tremor and Parkinson’s Disease. Under IRS Section 213(d), medical devices used for the diagnosis, cure, mitigation, treatment, or prevention of disease may qualify as eligible medical expenses. With a Letter of Medical Necessity from your healthcare provider, Steadi-3 may be eligible for FSA or HSA reimbursement as a medically necessary assistive device.