A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of multiple joints of the lower body which will include the knee (e.
| Company | Devices | Share |
|---|---|---|
| Orthopediatrics Corp. | 80 | 39% |
| Neotech Care Inc. | 56 | 28% |
| Comfy Health Group Co., Ltd. | 48 | 24% |
| Comfytopia, Inc. | 12 | 6% |
| Boston Brace International, Inc. | 4 | 2% |
| Medical Specialties Incorporated | 3 | 1% |
Company = labeler of record on GUDID. 6 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 | 117 |
| IQI | ORTHOSIS, LIMB BRACE | 92 |
| ITQ | Joint, Knee, External Brace | 21 |
| ITW | Joint, Ankle, External Brace | 15 |
| MRI | Orthosis, Truncal/Orthosis, Limb | 3 |
Use these as the dimensions to specify in a tender line.
203 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple-joint lower limb orthosis", from 6 companies. The largest labeler is Orthopediatrics Corp. with 39% of records.
IQI (Orthosis, Limb Brace), IQI (ORTHOSIS, LIMB BRACE), ITQ (Joint, Knee, External Brace), ITW (Joint, Ankle, External Brace)
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.