Medical Equipment Store: What It Is, What It Sells and What to Verify

This page describes products and general use; it is not medical advice.

A medical equipment store, also called a durable medical equipment (DME) store, sells or rents health-care equipment and supplies to patients, caregivers and facilities. If you are in the United States and a Medicare patient is involved, the label that matters is not the shop sign but whether the supplier is an enrolled Medicare DMEPOS supplier. This page shows how to tell equipment from supplies, what the federal rule requires of a Medicare supplier, and what to ask a store before buying or contracting. Who uses it: patients and caregivers, clinic and group-home staff, and buyers who need to qualify a supplier.

What a medical equipment store is

The everyday terms “medical equipment store,” “medical equipment and supplies store” and “DME store” point to the same kind of business: a retailer or rental provider of equipment used for a medical reason. In Medicare regulation the formal term is a DMEPOS supplier (durable medical equipment, prosthetics, orthotics and supplies). Under 42 CFR 424.57(a) that is an entity or individual that sells or rents Part B covered items to Medicare beneficiaries and meets the supplier standards in the rule (checked 2026-11-01).

For clinical background on individual products a store may sell, see our guides to wheelchairs, canes, CPAP machines and oxygen concentrators, and the respiratory therapy equipment overview.

Equipment or supplies: Medicare’s five-part DME test

Medicare.gov describes durable medical equipment as items that meet all of the following (checked 2026-11-01). The test is a quick way to decide whether an item sits on the equipment shelf or the supplies shelf.

Test	Medicare.gov wording
Durable	Can withstand repeated use
Medical reason	Used for a medical reason
Who benefits	Typically only useful to someone who is sick or injured
Where used	Used in your home
Lifespan	Expected to last at least 3 years

Medicare.gov lists canes, commode chairs, crutches, hospital beds, walkers, wheelchairs and scooters as examples. An item that is used up or discarded after use does not meet the “durable” and lifespan tests, so it is a supply rather than DME under this test. For supply planning in facilities, see the group home medical supply checklist and the physical therapy equipment list.

What makes a store a Medicare supplier

Medicare.gov states that Medicare pays for DME only when it comes from suppliers enrolled in Medicare, and advises confirming that the supplier will accept assignment. The enrollment rule, 42 CFR 424.57, sets the conditions below (Cornell Law School’s Legal Information Institute, checked 2026-11-01).

Requirement	What the rule says	Citation
Accreditation	Suppliers and all of their locations must meet the DMEPOS quality standards and be separately accredited to enroll in and bill Medicare	424.57(c)(22)(i)
Physical facility	Must maintain a physical facility on an appropriate site that is accessible to the public, beneficiaries and CMS	424.57(c)(7)
Staffed hours	The facility must be accessible and staffed during posted hours of operation	424.57(c)(7)
Open to the public	Open a minimum of 30 hours per week, with exceptions for certain physicians, therapists and custom orthotics/prosthetics suppliers	424.57(c)(30)
Surety bond	A $50,000 surety bond is submitted with enrollment (a regulatory requirement for the supplier, not a price of any product)	424.57(d)(2)

FDA classes of the devices on the shelf

The items a store carries are medical devices, and the FDA sorts devices by risk. According to FDA’s guidance on classifying a medical device, Class I includes devices with the lowest risk and Class III those with the greatest risk. For Class I or II devices that are not exempt, a 510(k) is required for marketing; Class III devices generally need premarket approval (PMA), with an exception for certain preamendments devices (checked 2026-11-01). The class of a specific product is a fact about that product, so ask the store or manufacturer for the product’s labeling rather than assuming it from the shelf it sits on.

What to verify before you buy or contract

• Medicare enrollment. If Medicare will be billed, confirm the supplier is enrolled and will accept assignment (Medicare.gov).
• Accreditation per location. The rule requires each location to be separately accredited, so ask about the specific address you will use.
• Physical facility and hours. A Medicare supplier must keep a staffed, publicly accessible facility during posted hours.
• The item’s labeling. Ask for the manufacturer’s instructions for use and the FDA class of the product.
• Government buyers. Federal ordering has its own channel; see Federal Supply Schedule: VA FSS, the NAC and who can order.

Common mistakes

• Treating a consumable as DME. Items that fail the durability and lifespan tests are supplies.
• Assuming a store with several locations is accredited everywhere. The rule applies accreditation to every location.
• Assuming that a shop that sells equipment is a Medicare supplier. Medicare pays only for items from enrolled suppliers.

FAQ

What is a durable medical equipment store?

A business that sells or rents durable medical equipment: items that withstand repeated use, serve a medical reason, are typically useful only to someone who is sick or injured, are used in the home and are expected to last at least 3 years (Medicare.gov, 2026-11-01).

What is the difference between a medical equipment store and a medical supply store?

Equipment is durable and reusable, such as walkers and hospital beds. Supplies are used up or discarded. Many stores carry both, which is why the Medicare test above is useful for sorting items.

Does a medical equipment store have to be a Medicare supplier?

Medicare pays for DME only when it comes from an enrolled supplier (Medicare.gov), and an enrolled DMEPOS supplier must meet the conditions in 42 CFR 424.57.

Sources

• Medicare.gov, Durable medical equipment (DME) coverage, checked 2026-11-01.
• 42 CFR 424.57, Special payment rules: DMEPOS supplier standards (Cornell LII), checked 2026-11-01.
• U.S. FDA, Classify your medical device, checked 2026-11-01.