A prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device.
| Company | Devices | Share |
|---|---|---|
| Deroyal Industries, Inc. | 152 | 31% |
| Bird & Cronin, Llc | 54 | 11% |
| Blake Manufacturing, Inc. | 49 | 10% |
| Reabilitimed Tov | 46 | 9% |
| Medi Manufacturing, Inc. | 45 | 9% |
| Djo, Llc | 39 | 8% |
| Hengshui Tianjian Medical Supplies Co.,Ltd | 20 | 4% |
| Darco (Europe) Gmbh | 16 | 3% |
| Tetra Medical Supply Corp. | 13 | 3% |
| Pantymed S.A. | 13 | 3% |
| Nea International B.V. | 7 | 1% |
| Hausmann Enterprises, Llc | 6 | 1% |
Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| IQI | ORTHOSIS, LIMB BRACE | 241 |
| IQI | Orthosis, Limb Brace | 140 |
| IOY | Support, Arm | 50 |
| ILH | Splint, Hand, And Components | 19 |
| IOY | SUPPORT, ARM | 16 |
| ILI | Sling, Arm | 13 |
Use these as the dimensions to specify in a tender line.
487 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Elbow orthosis", from 22 companies. The largest labeler is Deroyal Industries, Inc. with 31% of records.
IQI (ORTHOSIS, LIMB BRACE), IQI (Orthosis, Limb Brace), IOY (Support, Arm), ILH (Splint, Hand, And Components)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.