Types of Medical Equipment: FDA Classes, DME Test and Setting

General product information only, not medical advice. Sources checked 2026-11-01.

Medical equipment is not one official list. Regulators and payers sort it with two tests: the FDA asks whether an item is a medical device and which risk class it falls in, and Medicare asks whether it is durable medical equipment (DME) for home use. Use the class to see how an item reaches the market, and the DME test to see whether it is home-use equipment of the kind Medicare describes.

Overview

WHO describes medical devices as health technologies used to diagnose illness, monitor treatments, assist disabled people and intervene in or treat acute and chronic illness. It estimates about 2 million different kinds of medical devices on the world market, grouped into more than 7,000 generic device groups, so any short list is a simplification.

Under section 201(h) of the Federal Food, Drug, and Cosmetic Act, a device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or similar article, including a component part or accessory, intended for diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or function of the body, that does not achieve its primary purpose through chemical action in or on the body. For packaged consumables and kits, see medical supplies names.

Types of medical equipment: decision table

Groups below follow the purposes WHO lists, with the example items Medicare names as covered DME. A group is a purpose, not an FDA class: class is assigned per device type.

Type	What it is	Examples (as named by Medicare or WHO)	Limits to know
Assistive and mobility	Equipment that assists people with disabilities or injury	Canes, crutches, walkers, wheelchairs and scooters, commode chairs	Medicare covers different kinds of DME in different ways.
Respiratory and oxygen	Equipment for breathing support and oxygen delivery	CPAP therapy, oxygen equipment and accessories (including oxygen humidifiers), respiratory assist devices, high frequency chest oscillation devices	Medicare DME applies to equipment used in the home.
Monitoring	Equipment used to monitor a condition or treatment	Glucose monitors and related supplies, including test strips, control solutions and lancets	Supplies are listed separately from the monitor itself.
Infusion and treatment	Equipment that delivers or supports treatment	Infusion pumps and supplies, lymphedema powered devices	An FDA class applies to each device type, not to the group.
Beds and patient support	Equipment that supports the patient	Hospital beds	Medicare DME applies to equipment used in the home.
Diagnostic reagents	Items that test samples outside the body	In vitro reagents, named in the FDA device definition	They count as devices when they do not act chemically within or on the body.

For examples inside specific groups, see scooter vs power wheelchair and endocavity ultrasound probes.

FDA risk classes

The FDA assigns devices to three classes based on the level of control needed to assure safety and effectiveness. Class I includes devices with the lowest risk and Class III those with the greatest risk.

Class	Controls	Usual premarket route
Class I	General controls	Many are exempt from premarket notification; if not exempt, a 510(k)
Class II	General controls and special controls	510(k) clearance for most; some are exempt
Class III	General controls and premarket approval	Premarket approval (PMA) for most

The FDA states that approximately 572, or 74%, of Class I devices are exempt from the premarket notification process. To find the class of a specific device, search part of its name in the FDA classification database; the result usually identifies the classification regulation in 21 CFR. A formal determination can be requested from the FDA through a 513(g) request. For a worked example of reading classes by instrument, see spine surgery instruments and FDA classes.

How to choose by setting (home care, clinic, hospital, lab)

Setting	Test that applies	What it tells you
Home care	Medicare DME definition, plus the FDA device class	DME is durable (withstands repeated use), used for a medical reason, typically only useful to someone sick or injured, used in the home, and expected to last at least 3 years.
Clinic	FDA device definition and class	Whether the item is a device and how it reached the market (exempt, 510(k) or PMA).
Hospital	FDA device definition and class	The same class and pathway checks apply; the home-use element of the DME test does not.
Lab	FDA device definition (it includes in vitro reagents) and class	Whether a lab-use article is a device and which class its regulation assigns.

The 3-year expectation is Medicare’s coverage test, not a general definition of durable equipment. For the ordering paperwork that DME involves, see standard written order for DME.

What to check on the label

Note the device name and manufacturer, then search the product type in the FDA classification database to see its class and whether it needs a 510(k) or PMA. What a device label must carry is covered in FDA labeling requirements for medical devices.

Care and replacement

Use, cleaning, maintenance and replacement intervals come from the manufacturer’s instructions for use, not from the equipment category. Keep the instructions with the item.

FAQ

What counts as durable medical equipment?

For Medicare, DME is equipment that is durable (can withstand repeated use), used for a medical reason, typically only useful to someone who is sick or injured, used in your home, and expected to last at least 3 years.

How does the FDA classify medical devices?

Into Class I, II or III by risk: Class I is lowest risk, Class III is greatest. Class decides the premarket route: exemption or 510(k) for Classes I and II, and premarket approval for most Class III devices.

How many kinds of medical devices are there?

WHO estimates about 2 million kinds on the world market, in more than 7,000 generic device groups.

Sources

• FDA, How to Determine if Your Product is a Medical Device, checked 2026-11-01.
• FDA, Classify Your Medical Device, checked 2026-11-01.
• Medicare.gov, Durable medical equipment (DME) coverage, checked 2026-11-01.
• WHO, Medical devices, checked 2026-11-01.