Consulting Wallah › Device Explorer › Orthoses & supports › Shoulder immobilizer/orthosis, reusable
Device Explorer · FDA GUDID · GMDN 12101

Shoulder immobilizer/orthosis, reusable

A prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the

US‑registered devices243in commercial distribution
Companies14labelers on GUDID
Single‑use37%of device records
Sterile5%labelled sterile
Prescription59%Rx‑only share
ShareLinkedIn

Share of device records

Deroyal Industries, Inc.14258%
Vive Health Llc2611%
Medical Specialties Incorporated177%
Manamed, Inc.125%
Djo, Llc115%
Darco (Europe) Gmbh94%
Nea International B.V.94%
Tetra Medical Supply Corp.62%

Top labelers

CompanyDevicesShare
Deroyal Industries, Inc.14258%
Vive Health Llc2611%
Medical Specialties Incorporated177%
Manamed, Inc.125%
Djo, Llc115%
Darco (Europe) Gmbh94%
Nea International B.V.94%
Tetra Medical Supply Corp.62%
Asp Global, Llc42%
Elite Orthopaedics, Inc.31%
Tianjin Tairuibosi Medical Appliance Co.,Ltd.10%
Gcmedica Enterprise Ltd.(Wuxi)10%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TairuibosiShoulder BraceDONJOYViveCoreTechPERFORMANCE HEALTHVIVEArtic FlexArctic FlexElite OrthopaedicsKangaroo 3960Shoulder Brace with Airplane Kit LOGOShoulder Brace with Airplane KitManaMedOutrigger II Shoulder ImmobilizerVector Abducted Shoulder Immobilizer

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
ILISLING, ARM144
ILISling, Arm37
IQIORTHOSIS, LIMB BRACE19
ITQJoint, Knee, External Brace18
IQJSPLINT, CLAVICLE8
IQQJoint, Shoulder, External Limb Component6

GMDN & GCC registration

  • GMDN code 12101 · non‑implantable
  • Single‑use 37% · sterile 5% · Rx‑only 59% · OTC 21%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many shoulder immobilizer/orthosis, reusable products are registered in the US?

243 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Shoulder immobilizer/orthosis, reusable", from 14 companies. The largest labeler is Deroyal Industries, Inc. with 58% of records.

Which FDA product codes apply?

ILI (SLING, ARM), ILI (Sling, Arm), IQI (ORTHOSIS, LIMB BRACE), ITQ (Joint, Knee, External Brace)

Is this the same as UAE/GCC registration?

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.

How do I get quotes?

Add shoulder immobilizer/orthosis, reusable to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Shoulder immobilizer/orthosis, reusable

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying shoulder immobilizer/orthosis, reusable for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →