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What Is a Geriatric Chair? FDA Class and Types

A geriatric chair is FDA product code FRJ, Class I under 21 CFR 880.6140. See how it differs from treatment and blood donor chairs.

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

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A geriatric chair is a medical chair that the U.S. Food and Drug Administration (FDA) lists as its own device type, “Chair, Geriatric” (product code FRJ). It is a Class I device under 21 CFR 880.6140, the same regulation that covers treatment and blood donor chairs. This page is for clinic staff, buyers and students who need to know what the term means in regulatory terms and how a geriatric chair differs from the other chairs in that group.

What is a geriatric chair?

In FDA’s classification database, “Chair, Geriatric” (FRJ) is a medical chair intended for use by geriatric patients. The regulation defines the whole group as a chair or table “intended for use of blood donors, geriatric patients, or patients undergoing treatment or examination.” Who uses it: geriatric patients, as the regulation describes the intended user.

How is it built?

The regulation names the features that set these chairs apart from an ordinary chair. A medical chair has a “special shape or attachments, such as food trays or headrests, or special features such as a built-in raising and lowering mechanism or removable arms.” These are the only construction details the regulation specifies. It does not set dimensions, weight capacities or materials.

What does the FDA rule actually say?

21 CFR 880.6140 (Medical chair and table), checked 2026-10-30, has two parts that matter for this page.

  • Identification: the device “consists of a chair or table without wheels and not electrically powered.”
  • Classification: Class I (general controls). It is exempt from premarket notification (510(k)) procedures, subject to the limitations in 21 CFR 880.9. It is also exempt from the quality management system requirements in part 820, except the requirements concerning records and complaint files.

The identification wording describes a chair “without wheels and not electrically powered.” This page does not say which regulatory category a wheeled or powered chair belongs to, because the regulation text does not address that. The classification of a specific product can be confirmed with its manufacturer or in FDA’s device databases.

Geriatric, treatment and blood donor chairs compared

All three are listed under the same regulation. FDA’s classification database (openFDA, checked 2026-10-30) gives them separate product codes.

Type FDA product code Device class Use as the regulation describes it
Geriatric chair FRJ (“Chair, Geriatric”) Class I Geriatric patients
Treatment chair FRK (“Chair, Examination And Treatment”) Class I Patients undergoing treatment or examination
Blood donor chair FML (“Chair, Blood Donor”) Class I Blood donors

The key difference is the stated intended user, not a different regulation. For the blood donor variant, see phlebotomy chairs. All three codes carry the same classification record in openFDA: regulation 880.6140, General Hospital review panel, exempt from good manufacturing practice requirements.

How to choose: what the sources say

The FDA regulation lists the features that qualify a chair as this device type: a food tray or headrest attachment, a built-in raising and lowering mechanism, or removable arms. If you are matching a product to a requirement, those are the features the regulation names. The regulation does not rank them or recommend any of them.

In nursing facilities, federal rules add one more point to check. Under 42 CFR 483.10(e)(1) (checked 2026-10-30), a nursing-facility resident has “the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident’s medical symptoms, consistent with § 483.12(a)(2).” Whether a given attachment or chair position counts as a restraint is a question for the facility’s own restraint policy and clinical staff.

Safe use and handling basics

  • Follow the manufacturer’s instructions for use for the specific chair; the FDA regulation does not set operating instructions.
  • Use the chair for the intended user described above: geriatric patients, patients undergoing treatment or examination, or blood donors.
  • In a nursing facility, trays and similar attachments fall under the facility’s restraint policy, as described in the section above.

Common mistakes

  • Assuming Class I means no requirements. Class I devices are subject to general controls; the exemptions in 880.6140 cover premarket notification and most quality system requirements, not every rule.
  • Treating all chairs sold as geriatric chairs as the same regulated device. The identification text describes a chair without wheels that is not electrically powered, so compare the product’s actual design against it.
  • Ignoring the facility restraint rule when a tray is attached. Attachments such as food trays are named in the regulation as a design feature; their use in a nursing facility still falls under that facility’s restraint rules.

Frequently asked questions

Is a geriatric chair a medical device?

Yes. FDA lists “Chair, Geriatric” (product code FRJ) as a Class I device under 21 CFR 880.6140.

Does a geriatric chair need FDA 510(k) clearance?

Under 21 CFR 880.6140(b), the device is exempt from the premarket notification procedures, subject to the limitations in 21 CFR 880.9.

What is the difference between a geriatric chair, a treatment chair and a blood donor chair?

They share one regulation. The difference is the intended user named in it: geriatric patients, patients undergoing treatment or examination, or blood donors.

See also wheelchairs, hospital beds, transfer benches, and what counts as a medical device.

Sources

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