Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
Who uses it: clinic staff, buyers and students who need to know what the product class is and how it is regulated. Drugs.com CareNotes lists neck injury and arthritis among the situations where a clinician may recommend one, and Aspen Healthcare lists muscle tension and minor neck injuries on its product page.
What is a soft cervical collar?
A soft cervical collar is a foam device that wraps around the neck, fastens at the back and helps limit neck movement. Drugs.com CareNotes (last updated 4 October 2026) describes it as “made of soft foam” that “wraps around your neck, and fastens in the back”. One manufacturer, Aspen Healthcare, says its soft foam collar “provides limited cervical motion control” and serves as “a reminder against making quick and painful neck movements”.
That is the key difference from rigid and semi-rigid collars: a soft collar limits and reminds; it is not described as immobilising the neck. It is not an emergency or trauma collar. For rigid and semi-rigid designs, see what a cervical collar is and the cervical collar types and sizing guide. Related support devices are covered in what a splint is and back brace types.
How a soft cervical collar is built
The example product described here, Aspen Healthcare’s OTC Soft Foam Cervical Collar, lists soft polyfoam padding that conforms to the neck, a contoured shape that fits the chin and jaw, a lightweight breathable stockinette covering and a hook-and-loop closure at the back. Other makers’ designs may differ; the label of the specific product governs.
How FDA regulates a soft cervical collar
Cervical orthoses fall under 21 CFR 890.3490, “Truncal orthosis”. The regulation defines the device as one “intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body” and names cervical orthoses among its examples. It classifies the device as Class I (general controls), exempt from 510(k) premarket notification subject to the limitations in 21 CFR 890.9, and exempt from the quality management system requirements of 21 CFR part 820 except records and complaint files (820.35).
The openFDA classification database lists product code IQK, “Orthosis, Cervical”, as Class 1 under regulation 890.3490 with the GMP-exempt flag set. The database does not separate soft from rigid collars, so the code is not specific to soft foam designs.
Soft collar sizes: one manufacturer’s chart
Sizing is set by each manufacturer, so there is no universal size chart. As one labelled example, Aspen Healthcare sizes its soft foam collar by neck circumference:
| Size | Neck circumference (inches) | Neck circumference (cm) |
|---|---|---|
| Small | 13.5 to 15.5 | 34.3 to 39.4 |
| Medium | 15.5 to 17.5 | 39.4 to 44.4 |
| Large | 17.5 to 19.5 | 44.4 to 49.5 |
Source: Aspen Healthcare, OTC Soft Foam Cervical Collar product page, checked 30 October 2026. Other brands use their own ranges.
Soft cervical collar and sleeping
Can you sleep in a soft cervical collar? Sources describe it differently, and wear time is set by the clinician who recommended the collar and by the product’s own label.
| Source | What it says |
|---|---|
| Drugs.com CareNotes (patient education) | Treats sleeping as a topic to raise with the clinician and refers wear time to them. |
| Aspen Healthcare (manufacturer) | Describes its soft foam collar as “especially convenient for wear while sleeping”. |
Handling and labelling basics
- Instructions for use come from the product label and the clinician; this page does not replace either.
- Aspen’s label says a correctly applied collar “should fit snug but not so tight that it causes discomfort”.
- The collar is a limited-motion device, not an emergency or rigid collar, so its labelling should be read for what the maker claims it does.
Common misunderstandings
- Treating a soft collar as an emergency or rigid collar. Its labelled role is limited motion control and a reminder, not immobilisation.
- Assuming one size chart fits every brand. Manufacturers size by neck circumference against their own chart.
FAQ
What is a soft cervical collar used for?
Drugs.com CareNotes says it helps limit neck movement and lists neck injury and arthritis among the reasons a clinician may recommend one. Aspen Healthcare lists muscle tension and minor neck pain or injuries among its product’s indications.
Is a soft cervical collar a medical device?
Yes. Cervical orthoses are Class I devices under 21 CFR 890.3490, exempt from 510(k) subject to 21 CFR 890.9 limitations.
Can I sleep in a soft cervical collar?
One manufacturer describes its soft foam collar as convenient for wear while sleeping. Wear time is set by the clinician and the product label.
How is a soft collar sized?
By neck circumference against the manufacturer’s chart; see the example above.
Sources
- eCFR via Cornell LII, 21 CFR 890.3490 Truncal orthosis, https://www.law.cornell.edu/cfr/text/21/890.3490 (checked 30 October 2026)
- openFDA device classification API, product code IQK, https://api.fda.gov/device/classification.json?search=product_code:IQK (checked 30 October 2026)
- Drugs.com CareNotes, Soft Cervical Collar, https://www.drugs.com/cg/soft-cervical-collar.html (updated 4 October 2026; checked 30 October 2026)
- Aspen Healthcare, OTC Soft Foam Cervical Collar, https://aspenhealthcare.ca/products/otc-foam-cervical-collar (checked 30 October 2026)
