Rehabilitation Products: Categories, FDA Classes and What to Verify

Short answer: “Rehabilitation product” is a trade and shopping label, not a defined regulatory term. Most of what it covers (canes, walkers, wheelchairs, orthoses, exercise equipment, hot and cold packs, muscle stimulators) falls under the FDA’s physical medicine devices regulation, 21 CFR Part 890, and those devices range from Class I (lowest risk) to Class III (greatest risk). A device’s regulation number, class and intended use are the fastest way to tell what a given product actually is.

General information only; this page is not medical advice and does not recommend a product for any person or condition.

What counts as a rehabilitation product

Suppliers and catalogues use the phrase, and variants such as rehab aids, rehabilitation aids, rehabilitation supplies and pain rehab products, to group equipment used in physical and occupational therapy and in recovery after injury or illness. No regulation defines the phrase, and 21 CFR Part 890 does not use it. What does exist is FDA’s Part 890, titled “Physical Medicine Devices”, which sets out “the classification of physical medicine devices intended for human use that are in commercial distribution” (21 CFR 890.1(a)). Read as a category map, Part 890 is the closest official structure for the products people search for under this name.

The same section adds a caution that matters for sourcing: the identification of a device in a Part 890 regulation “is not a precise description of every device that is, or will be, subject to the regulation” (21 CFR 890.1(b)). A product that sits near a listed device is not automatically covered by that entry.

How FDA groups physical medicine devices (Part 890)

Part 890 is organised into subparts by function. As published in the eCFR (checked 2026-11-01):

• Subpart B, Physical Medicine Diagnostic Devices: measurement and testing equipment, for example a diagnostic electromyograph or an isokinetic testing and evaluation system.
• Subpart D, Physical Medicine Prosthetic Devices: despite the title, this subpart also lists mobility and positioning equipment such as canes, crutches, walkers, wheelchairs, limb orthoses and plinths, alongside prosthetic components.
• Subpart F, Physical Medicine Therapeutic Devices: exercise equipment, hot and cold packs, massagers, stimulators, traction equipment and therapy beds.
• Subparts C and E are reserved.

FDA assigns each device type to a risk class. Per FDA’s page Classify Your Medical Device (checked 2026-11-01), Class I means general controls and “includes devices with the lowest risk”, Class II means general controls and special controls, and Class III means general controls and premarket approval and “includes those with the greatest risk”. The page also states that classification depends on a device’s intended use and its indications for use.

Examples by subpart and class

The table lists devices named in Part 890, with the section and class as stated in the eCFR on 2026-11-01. It is a selection, not the complete part.

Device type	Regulation	Subpart	Class
Cane	21 CFR 890.3075	D	I
Mechanical walker	21 CFR 890.3825	D	I
Mechanical wheelchair	21 CFR 890.3850	D	I
Powered wheelchair	21 CFR 890.3860	D	II
Limb orthosis	21 CFR 890.3475	D	I
Powered lower extremity exoskeleton	21 CFR 890.3480	D	II
Rigid pneumatic structure orthosis	21 CFR 890.3610	D	III
Diagnostic electromyograph	21 CFR 890.1375	B	II
Isokinetic testing and evaluation system	21 CFR 890.1925	B	II
Daily activity assist device	21 CFR 890.5050	F	I
Powered exercise equipment	21 CFR 890.5380	F	I
Cold pack	21 CFR 890.5700	F	I
Powered heating pad	21 CFR 890.5740	F	II
Air-fluidized bed	21 CFR 890.5160	F	II
Powered muscle stimulator	21 CFR 890.5850	F	II

Two things stand out. First, products that a catalogue would shelve together span all three classes: a cold pack and a powered exercise machine are Class I, a powered heating pad and an air-fluidized bed are Class II, and a rigid pneumatic structure orthosis is Class III. Second, a name that sounds the same can sit in different classes: a mechanical wheelchair is Class I while a powered wheelchair is Class II. For how specific items are used in practice, see CASRAI’s guides to what a cane is, what a wheelchair is and treadmills used in rehabilitation.

What to verify when specifying or sourcing rehabilitation supplies

This checklist applies equally when the search was for rehab aids, rehabilitation aids, rehabilitation supplies or a rehabilitation supplier. Each item follows from FDA’s classification framework described above.

1. Identify the device type. Each classified device has a seven-digit regulation number pointing to a section of the CFR. For physical medicine devices, look in 21 CFR Part 890.
2. Find the class. Class I, II or III tells you the level of regulatory control FDA applies to that device type.
3. Find the product code. FDA also assigns a three-letter product code to each device type (FDA’s example is FLK for a clinical mercury thermometer), which lets you look the type up in FDA’s databases.
4. Match intended use and indications. Classification depends on intended use and indications for use, so a product described for a different use than the one you have in mind is not covered by the same classification.

For equipment-rich settings, CASRAI also covers a supply checklist for inpatient rehabilitation facilities and the equipment found in an athletic training room. For the profession these products support, see what physical therapy is.

Common misunderstandings

• “Rehabilitation product” is a regulated category. It is not a defined term in Part 890; the regulation classifies individual device types.
• All rehab equipment carries the same level of control. The table above shows Class I, II and III entries in one part of the CFR.
• A similar name means the same classification. Mechanical and powered wheelchairs are separate entries with different classes, and section 890.1(b) cautions that an identification is not a precise description of every device.

FAQ

What is a rehabilitation product?

It is a general term for equipment and supplies used in rehabilitation and therapy. It has no official definition; FDA classifies the underlying devices by type under 21 CFR Part 890 (physical medicine devices).

Are rehab aids and rehabilitation aids the same thing?

The terms are used interchangeably in everyday and catalogue language. Neither is defined in the CFR, so identify the actual device type and its regulation number instead.

How do I find the FDA class of a rehabilitation device?

Find the device type in 21 CFR Part 890 and read the classification paragraph of its section, or use the device’s product code in FDA’s databases. Class depends on intended use and indications for use.

Do rehabilitation supplies fall under one regulation?

Many do fall under Part 890, in its diagnostic, prosthetic and therapeutic subparts, but the part covers only classified physical medicine device types and each type has its own section.

Sources

• eCFR, 21 CFR Part 890, Physical Medicine Devices, sections 890.1 and 890.1175 to 890.5975 (checked 2026-11-01).
• U.S. Food and Drug Administration, Classify Your Medical Device (checked 2026-11-01).