What Is a Posey Vest? Definition, FDA Class and CMS Restraint Rules

General product and regulatory information for lab, clinic and supply staff. This page is not medical advice and does not describe how to apply any device to a patient.

Short answer

“Posey vest” is the name people use for a vest-style protective restraint, a garment worn on the torso that limits a patient’s movement. The name comes from J. T. Posey Co., which is listed as the applicant on FDA 510(k) record K963442 for a device named “Jackets and Vests”. In US regulation the device type is a Class I protective restraint under 21 CFR 880.6760, and whether its use counts as a restraint in a hospital is decided by the CMS rule at 42 CFR 482.13(e).

Definition and scope

The FDA does not regulate a product by its brand name. It regulates the device type. Under 21 CFR 880.6760, a protective restraint is “a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient’s movements to the extent necessary for treatment, examination, or protection of the patient or others.” A vest is named in that list, so a vest-style restraint from any manufacturer falls under the same regulation.

Two separate rule sets meet on this one product, and they answer different questions:

• FDA (the device): what the product is, its class and how it may be marketed.
• CMS (the use): when using a product on a hospital patient counts as a restraint, and what the hospital must do when it is used.

For the wider category, including other restraint types, see our guide to medical restraints.

How the regulatory chain works in practice

The FDA side

Section 880.6760(b) classifies protective restraints as Class I (general controls) and exempts the device from the premarket notification procedures in subpart E of part 807, subject to the limitations in 21 CFR 880.9. The FDA 510(k) database nonetheless holds a record for a Posey product: K963442, device name “Jackets and Vests”, applicant J. T. Posey Co., regulation number 880.6760, product code FMQ, received 08/30/1996 with a decision of Substantially Equivalent on 11/22/1996. That record is a useful example of how a brand name maps to a generic device name and product code: the FDA entry says “Jackets and Vests”, not “Posey vest”.

The CMS side

The hospital Condition of Participation at 42 CFR 482.13(e) defines a restraint by effect, not by product: “any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely.” A vest therefore matters under this rule when its use limits free movement. Our guide to the CMS patient rights Condition of Participation covers the rest of section 482.13.

The regulation places these conditions on use:

• A restraint may be used only when less restrictive interventions have been determined to be ineffective (482.13(e)(2)).
• The hospital must use the least restrictive intervention that will be effective (482.13(e)(3)).
• Use requires an order from a physician or other licensed practitioner responsible for the patient’s care (482.13(e)(5)).
• Staff must be trained and able to demonstrate competency before taking part in restraint use, and the training content in 482.13(f) includes recognising signs of distress such as positional asphyxia.
• Hospitals must report deaths associated with the use of restraint as 482.13(g) specifies.

These are facility-policy points for staff who write or audit policy; they are not instructions for applying a device.

Types and related concepts

The table below compares only what the sources above state about the term “vest” and its neighbours.

Item	What the source says	Source
Protective restraint (device type)	Includes vest, wristlet, anklet, mitt, straight jacket, body/limb holder or other strap; Class I; exempt from 510(k) subject to 880.9	21 CFR 880.6760
Product code FMQ	Restraint, Protective; used on the Posey “Jackets and Vests” 510(k) record	FDA 510(k) K963442
Restraint (hospital use)	Any manual method, physical or mechanical device, material or equipment that immobilizes or reduces free movement of arms, legs, body or head	42 CFR 482.13(e)(1)(i)(A)

Other patient-positioning and restraint-adjacent products are covered separately, for example the papoose board and the geriatric chair.

Where it matters for labs, clinics and supply decisions

For anyone who writes policy or reviews a supplier listing, the sources support a short verification checklist. Each line is a check, not a recommendation to buy or avoid any product.

1. Match the name to the regulation. Confirm the listing identifies a protective restraint under 21 CFR 880.6760 and not only a brand name.
2. Check the FDA record. The product code for protective restraints is FMQ; the 510(k) database shows the device name and applicant for records such as K963442.
3. Read the manufacturer’s instructions for use. Labeling and instructions come from the manufacturer; this page does not reproduce them.
4. Compare facility policy with 482.13(e). A hospital’s policy must reflect the order, least-restrictive, training and death-reporting provisions above, and any applicable State law.
5. Keep the device rule and the use rule apart. A device being Class I and 510(k)-exempt says nothing about whether a particular use is allowed in a given patient.

Environment-of-care assessments sit in related territory; see ligature risk assessment.

Common misunderstandings

• “Posey vest” is an FDA device category. It is not. The FDA entry is a generic device name and a product code; the brand is the applicant’s.
• Class I means no rules. Class I devices are subject to general controls, and in hospitals the CMS use rules in 482.13(e) apply on top of the device classification.
• A vest is always a restraint. Under the CMS definition the test is whether the item immobilizes or reduces the ability to move freely.

FAQ

What is a Posey vest?

It is a vest-style protective restraint associated with J. T. Posey Co. The FDA regulates the device type as a protective restraint, Class I, under 21 CFR 880.6760.

Is a Posey vest FDA approved?

Protective restraints are Class I and exempt from premarket notification (subject to 21 CFR 880.9), so they are not “approved” through a premarket approval. The FDA database does list 510(k) K963442 for a Posey “Jackets and Vests” device, decided 11/22/1996.

What does CMS say about restraints in hospitals?

42 CFR 482.13(e) requires that a restraint be used only when less restrictive interventions are ineffective, be the least restrictive effective option, and be ordered by a physician or other licensed practitioner responsible for the patient.

Sources

• 21 CFR 880.6760, Protective restraint, eCFR, checked 2026-11-02.
• 42 CFR 482.13, Condition of participation: Patient’s rights, eCFR, checked 2026-11-02.
• FDA 510(k) record K963442, AccessData 510(k) database, checked 2026-11-02.