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General information about how US federal rules treat the different kinds of therapy supplier. It is not legal, regulatory or medical advice.
Short answer
A therapy supplier is a business that sells equipment and supplies used in physical, occupational and rehabilitation therapy. The name covers different roles: a manufacturer, a distributor and a retail or dispensing outlet each carry different US regulatory duties. So the useful buying question is not whether a supplier is “FDA approved” but which role it plays, which devices it sells and which documents it can show for them.
Definition and scope
“Therapy supplier” is used for sellers of rehabilitation products, physical therapy equipment and occupational therapy equipment. This page does not rank or recommend any supplier. It does not list products either: for categories and FDA classes see the physical therapy equipment list and rehabilitation products guide. The page covers one task: working out what kind of supplier you are dealing with and what to ask it to show. A related page covers the same question for massage suppliers, and medical equipment stores are a retail variant.
Variants of the term
- Rehabilitation suppliers – sellers of rehabilitation products across disciplines.
- Physical therapy equipment suppliers – sellers of equipment such as exercise and mobility devices.
- Occupational therapy equipment suppliers – sellers of equipment for daily-living and hand-therapy work.
These are the same buying question applied to different catalogues, so one set of checks applies to all three.
How suppliers are used in practice
One trade publisher, Net Health, in its article on starting a physical therapy equipment purchase (checked 2026-11-02), lists eight sourcing channels: major medical supply distributors, specialty physical therapy and rehabilitation suppliers, direct purchase from manufacturers, online marketplaces, used-equipment dealers, online auctions, other clinics and leasing. It lists the “as-is” condition as a drawback of auctions and says they carry “no warranty or guarantee”. That is one publisher’s view, not a regulation. Each channel puts a different party between you and the manufacturer, which is why the role check below comes first.
Types of supplier and what US rules say about each
| Role | What the source says | Source |
|---|---|---|
| Establishment that makes or distributes devices for US use | Owners and operators are required to register annually with FDA; establishments that must register generally also list the devices made there, and for devices needing marketing authorization provide the premarket submission number (510(k), De Novo or PMA). | FDA, Device Registration and Listing (checked 2026-11-02) |
| Retail or dispensing outlet | 21 CFR 807.65 lists exemptions from registration including “pharmacies, surgical supply outlets, or other similar retail establishments” and persons who dispense devices to the ultimate consumer. | 21 CFR 807.65, eCFR (checked 2026-11-02) |
| Manufacturer of general-purpose articles | The same section exempts makers of raw materials or components and of general purpose articles. | 21 CFR 807.65, eCFR (checked 2026-11-02) |
FDA’s statement in the first row is the only rule cited here for distributors. Because 21 CFR 807.65 exempts retail and dispensing outlets, a supplier in that role may not hold its own registration, so it is reasonable to ask the supplier to name the manufacturer.
What to verify before buying
1. The role and the manufacturer
Ask which role the supplier plays for each item (manufacturer, distributor, retailer) and who the manufacturer is. FDA’s page says registered establishments must also list the devices made there, so a registration and listing number is a reasonable thing to ask for.
2. The marketing authorization claim, per device
Whether a premarket submission exists depends on the device. Powered exercise equipment, for example, is defined in 21 CFR 890.5380 as powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints, with a powered treadmill, a powered bicycle and powered parallel bars as examples. It is Class I (general controls) and exempt from premarket notification, subject to the limits in 21 CFR 890.9 (checked 2026-11-02). So for that kind of product, an “FDA cleared” claim is not what the classification would lead you to expect. Ask what the claim actually refers to, and see the rehabilitation products guide for class details on other categories.
3. Documents to request
| Document | Why it is useful | Where to read more |
|---|---|---|
| FDA registration and listing numbers; premarket submission number where one applies | Ties the claim to a record, per the FDA registration page. | FDA, Device Registration and Listing |
| Unique Device Identifier (UDI) for the device | Lets you look up the device record and match recalls to what you hold. | UDI guide |
| ISO 13485 certificate, including its scope and expiry | A certificate is a scope statement with an expiry date, so read what it covers and which sites it names. | ISO 13485 certification guide |
| Manufacturer instructions for use, warranty and service terms | These set out intended use and what happens after the sale. Net Health describes auction purchases as as-is with no warranty. | Manufacturer |
Common misunderstandings
- “A supplier must be FDA registered.” Not in every role. 21 CFR 807.65 exempts retail and dispensing outlets, among others, from registration.
- “Every device has been cleared.” Some device types, such as powered exercise equipment, are Class I and exempt from premarket notification.
FAQ
What is a therapy supplier?
A business that sells equipment and supplies for physical, occupational or rehabilitation therapy. It may be a manufacturer, a distributor or a retail outlet, and the role determines which US rules apply to it.
Do physical therapy equipment suppliers need FDA registration?
It depends on role. FDA states that owners and operators of establishments that make or distribute devices for US use must register annually. 21 CFR 807.65 lists exemptions, including retail establishments such as surgical supply outlets and persons who dispense devices to the ultimate consumer. Ask the supplier which role it plays.
What should I ask rehabilitation and occupational therapy equipment suppliers to show?
The same documents apply: manufacturer identity, registration and listing numbers where relevant, any premarket submission number, the UDI, the ISO 13485 certificate scope, instructions for use and warranty terms.
Sources
- FDA, Device Registration and Listing, checked 2026-11-02.
- eCFR, 21 CFR 807.65, Exemptions for device establishments, checked 2026-11-02.
- eCFR, 21 CFR 890.5380, Powered exercise equipment, checked 2026-11-02.
- Net Health, Physical Therapy Equipment: Start Your Search Here (trade publisher article on sourcing channels), checked 2026-11-02.
