Written and maintained by CASRAI Editorial Board
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General product and regulatory information only. This page is not medical advice and does not describe how to use a device on a patient.
Short answer
In medical supply, an arm board is a rigid or padded board that supports or holds an arm still. FDA lists “Board, Arm (With Cover)” under 21 CFR 878.3910, the noninflatable extremity splint regulation, as a Class I device. The same words are also used for operating-room table attachments, wheelchair armboards and radial-access boards, which FDA classifies differently.
Definition and scope: which “arm board”?
The phrase covers several unrelated products, and the regulatory record separates them. The computing sense (ARM microcontroller boards) is a different subject and is not covered here.
IV arm board
“IV arm board” is a common supply-catalogue phrase for a board that holds the forearm and hand still. FDA’s product codes do not carry an “IV” label: the closest codes, NOD and BTX, are named “Board, Arm (With Cover)” and sit under the regulation for a device “intended to immobilize a limb or an extremity.” For what an intravenous catheter itself is, see the guide what is an IV catheter.
How it is used in practice
The regulation describes the function in one line: a noninflatable extremity splint is “a device intended to immobilize a limb or an extremity. It is not inflatable.” That intended-use wording, rather than any specific clinical technique, is what the federal record states for the NOD and BTX arm board codes. Device-specific application steps come from the manufacturer’s instructions for use and from facility policy, not from this page. For the wider device family, see what a splint is and splint kit contents.
Types and related classifications
The table below is a cross-walk of the FDA product codes that carry “arm board” or “armboard” in their names, plus the operating-room table attachment code that appears on arm-board records in AccessGUDID. Every row comes from the FDA classification database (openFDA).
| FDA product code | Name in FDA database | Regulation | Class | Exempt from QMS (GMP) per database flag |
|---|---|---|---|---|
| NOD | Board, Arm (With Cover), Non-Sterile | 21 CFR 878.3910 | 1 | Yes |
| BTX | Board, Arm (With Cover), Sterile | 21 CFR 878.3910 | 1 | No |
| BWN | Table and Attachments, Operating-Room | 21 CFR 878.4950 | 1 | No |
| IMY | Armboard, Wheelchair | 21 CFR 890.3910 | 1 | Yes |
The wheelchair armboard is a seating accessory, not a limb splint; it appears in wheelchair accessories.
Where it matters for labs, clinics and supply decisions
Classification and sterile versus non-sterile
Under 21 CFR 878.3910(b), the noninflatable extremity splint is Class I (general controls) and exempt from premarket notification, subject to 21 CFR 878.9. If it is not labeled or represented as sterile, it is also exempt from the quality management system requirements of part 820 except records and complaint files (820.35). This is why FDA’s database flags the non-sterile code (NOD) as exempt and the sterile code (BTX) as not exempt. A listing’s sterility representation therefore changes which regulatory obligations apply to the maker.
Operating-room arm boards are coded under the table
The AccessGUDID record 04046768028784, “Arm board with SFC padding” from MAQUET GmbH, uses product code BWN, “Table and attachments, operating-room.” The record states it is not packaged sterile, requires no sterilization prior to use, is not single-use, and contains no MRI safety information in the labeling. An operating-table arm board is thus a table accessory in FDA’s scheme, not a 878.3910 splint. Record fields such as sterilization, single-use and MRI-safety labeling are visible to anyone searching AccessGUDID, which makes them useful for comparing listings.
What the published evidence does and does not show
- Schults and colleagues (Australian Critical Care, 2020) followed 100 peripheral arterial catheters in 89 children (472 device days). Nineteen devices (20%) failed. In univariate analysis, arm board immobilisation was associated with increased failure (hazard ratio 2.9; 95% CI 1.02 to 8.02; p = 0.05). This was an observational study of arterial catheters, so it does not show that arm boards cause failure and does not cover other catheters.
- Suryadevara and colleagues (Catheterization and Cardiovascular Interventions, 2020) ran a randomized trial of 265 patients with right radial access. A radio-dense radial arm board plus a pelvic drape produced a higher mean operator radiation dose (0.65 mSv) than standard shielding alone (0.56 mSv; P < 0.0001). The authors attributed this to the board preventing placement of the usual below-table shield insert, and the marketed 44% reduction was not borne out in that trial.
Both findings concern specific products and settings. They show that a board is not automatically protective, and they are not a recommendation for or against any product.
Common misunderstandings
- “Arm board” is one device. FDA records spread it across at least three regulations (878.3910, 878.4950, 890.3910).
- Class I means no rules. Class I devices remain under general controls; only specific premarket and QMS obligations are exempted, and the sterile code is not QMS-exempt.
- A board always improves outcomes. The two studies above found an association with higher catheter failure in one setting and higher operator dose in another.
- A transfer board is an arm board. They are different products; see how a transfer board is used.
FAQ
What is an IV arm board?
It is the common name for an arm board sold for holding an arm still around an IV. In FDA’s database the nearest entries are NOD (non-sterile) and BTX (sterile), both “Board, Arm (With Cover)” under 21 CFR 878.3910, Class I.
Is an arm board a medical device?
Yes in the FDA records above: the NOD, BTX, BWN and IMY codes are all Class I device classifications.
Does an arm board need FDA clearance?
The splint regulation exempts the device from premarket notification (510(k)), subject to 21 CFR 878.9.
Sources
- 21 CFR 878.3910, Noninflatable extremity splint, law.cornell.edu/cfr/text/21/878.3910, checked 2026-10-30.
- FDA product classification database via openFDA, product codes NOD, BTX, BWN, IMY, api.fda.gov/device/classification.json, checked 2026-10-30.
- AccessGUDID record 04046768028784, accessgudid.nlm.nih.gov, checked 2026-10-30.
- Schults JA et al., Aust Crit Care 2020;33(4):326-332, PMID 31201037, abstract checked 2026-10-30.
- Suryadevara R et al., Catheter Cardiovasc Interv 2020;95(1):83-88, PMID 30866175, abstract checked 2026-10-30.
