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General regulatory and product information for laboratory, clinic and supply staff. It is not medical advice and does not describe how to apply any device to a patient.
Short answer
Medical restraints are devices or methods that limit a patient’s movement. Two different federal frameworks describe them. FDA regulates the product: a “protective restraint” is a Class I device under 21 CFR 880.6760. CMS regulates the use: in hospitals, 42 CFR 482.13 defines what counts as a restraint and when one may be imposed. A wristlet on a supply shelf and a restraint on a patient are judged under different rules.
Definition and scope
FDA’s identification in 21 CFR 880.6760 reads: 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.” The product code is FMQ (“Restraint, Protective”), the review panel is General Hospital, and the device class is 1 (FDA product classification database, checked 2026-10-30).
The CMS hospital rule defines the term more broadly and by function. Under 42 CFR 482.13(e)(1)(i), a restraint is 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, or a drug or medication used as a restriction to manage behavior or restrict freedom of movement that is not a standard treatment or dosage for the patient’s condition.
How the FDA and CMS definitions fit together
| Question | FDA (21 CFR 880.6760) | CMS (42 CFR 482.13) |
|---|---|---|
| What is regulated | The device as a product | The use of restraint or seclusion on a hospital patient |
| What counts | Medical-purpose wristlet, anklet, vest, mitt, straight jacket, body/limb holder or other strap (list is “not limited to”) | Any manual method, physical or mechanical device, material or equipment that immobilizes or reduces free movement; plus certain drugs |
| Category | Class I, general controls | Condition of participation for hospitals |
| Premarket notification | Exempt from 510(k), subject to the limits in 21 CFR 880.9 | Not applicable |
Two practical consequences follow. A product can be a lawfully marketed protective restraint under FDA rules and still be a restraint that a hospital may use only within the CMS conditions. And an item that FDA does not list may still be a restraint under CMS if it immobilizes or reduces free movement.
Types named in the regulations
Types of restraints in the FDA identification
The wording of 21 CFR 880.6760 names these forms of protective restraint: wristlet, anklet, vest, mitt, straight jacket, body/limb holder, and other types of strap. “Wrist restraints” in everyday supply language correspond to the wristlet entry; the regulation uses the term wristlet and does not subdivide the list further.
Types in the CMS definition
- Physical or mechanical: a manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability to move arms, legs, body or head freely.
- Drug or medication: a drug used as a restriction to manage behavior or restrict freedom of movement that is not a standard treatment or dosage for the patient’s condition.
- Seclusion is defined separately in 482.13(e)(1)(ii) as involuntary confinement of a patient alone in a room or area the patient is physically prevented from leaving.
Is it a restraint under CMS? A checklist drawn from the rule
The text of 482.13(e)(1)(i) supports three questions, asked in order:
- Does the method, device, material or equipment immobilize the patient or reduce the ability to move arms, legs, body or head freely?
- Is it a drug or medication used to manage behavior or restrict movement that is not a standard treatment or dosage for the condition?
- Does it fall within the exclusions? The rule says a restraint does not include devices such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve physically holding a patient to conduct routine physical examinations or tests, to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm. A physical escort is not excluded.
This checklist is a reading aid for the definition, not a substitute for a facility’s policy or legal advice.
Where it matters for labs, clinics and supply decisions
- Product-side facts a buyer can confirm from FDA records: the product code (FMQ), the regulation number (880.6760), Class I status, and that the 510(k) exemption applies only within the limits of 21 CFR 880.9. Under that section, a manufacturer must still submit a premarket notification when a device is intended for a use different from the intended use of a legally marketed device of that generic type, or uses a different fundamental scientific technology.
- Use-side obligations sit with the hospital: the order, monitoring, training and least-restrictive requirements are covered in the CASRAI guide to restraint and seclusion under the CMS conditions of participation; this page does not repeat them.
- Wider rights framework: restraint is one part of the CMS patient rights condition of participation.
- Related patient-safety equipment: items such as a gait belt or a bed alarm are separate product topics; whether any item is a restraint in a given use depends on the CMS definition above.
- Manufacturers: design records for regulated devices are discussed in the design history file guide.
Common misunderstandings
- “If FDA lists it, it is always a restraint.” FDA’s list describes a product class. Whether a use is a restraint in a hospital is decided by 42 CFR 482.13.
- “Only straps and cuffs count.” The CMS definition covers manual methods, any material or equipment that reduces free movement, and certain drugs.
- “Anything that limits movement is a restraint.” The rule excludes orthopedically prescribed devices, surgical dressings and bandages, protective helmets, and certain holding for examinations or tests, bed-fall protection or safe participation in activities.
- “Class I and 510(k)-exempt means unregulated.” General controls still apply, and the exemption has the limits stated in 21 CFR 880.9.
FAQ
What are wrist restraints?
Wrist restraints are wristlets: one of the protective restraint forms named in 21 CFR 880.6760, a Class I device intended for medical purposes that limits movement only to the extent necessary for treatment, examination or protection of the patient or others.
What are the types of restraints?
FDA names wristlet, anklet, vest, mitt, straight jacket, body/limb holder and other straps. CMS describes physical or mechanical methods and devices, and certain drugs, and defines seclusion separately.
Are medical restraints regulated by FDA?
Yes. A protective restraint is a Class I device under product code FMQ and regulation 880.6760, exempt from premarket notification within the limits of 21 CFR 880.9.
Is a bandage or protective helmet a restraint?
Under 42 CFR 482.13(e)(1)(i)(C), a restraint does not include surgical dressings or bandages or protective helmets, among other listed devices and methods.
Sources
- 21 CFR 880.6760, Protective restraint, and 21 CFR 880.9, Limitations of exemptions from section 510(k): eCFR, https://www.ecfr.gov/current/title-21/part-880/subpart-G (checked 2026-10-30).
- FDA Product Classification, product code FMQ “Restraint, Protective”: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=FMQ and openFDA device classification, https://api.fda.gov/device/classification.json?search=product_code:FMQ (checked 2026-10-30).
- 42 CFR 482.13(e), Condition of participation: Patient’s rights, restraint or seclusion: eCFR, https://www.ecfr.gov/current/title-42/part-482/section-482.13 (checked 2026-10-30).
