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Device Explorer · FDA GUDID · GMDN 44851

Limb/torso/head restraint, single-use

A non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during

US‑registered devices491in commercial distribution
Companies38labelers on GUDID
Single‑use55%of device records
Sterile6%labelled sterile
Prescription70%Rx‑only share
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Share of device records

Deroyal Industries, Inc.23548%
Morrison Medical, Ltd439%
Isys Medizintechnik Gmbh265%
Djo, Llc184%
Ace Surgical Supply Co., Inc.184%
Bird & Cronin, Llc163%
Ekcomed, Inc.143%
Alphatec Spine, Inc.133%

Top labelers

CompanyDevicesShare
Deroyal Industries, Inc.23548%
Morrison Medical, Ltd439%
Isys Medizintechnik Gmbh265%
Djo, Llc184%
Ace Surgical Supply Co., Inc.184%
Bird & Cronin, Llc163%
Ekcomed, Inc.143%
Alphatec Spine, Inc.133%
Xodus Medical, Inc.122%
Mizuho Orthopedic Systems, Inc.102%
Kenad Sg Medical, Inc.102%
Smith & Nephew, Inc.82%

Company = labeler of record on GUDID. 38 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Pivot GuardianNAPROCAREArthrex®Active Heel Traction BootN/AVelcro StrapJannus Pannus RetractorPanni Retractor SystemPannus Retention SystemEKCOMEDHANA SAFETY STRAP, SINGLE USESTRAP, POSITIONINGPKIT HANA DISTRACTION PAD STRAP"27"" SOFT STRAP, ARM BOARD STRAP"ULTRA SHOULDER POSITIONER STRAP SET 50/C

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

FDA product codes

CodeNameDevices
FMQRestraint, protective265
FMQRestraint, Protective91
CCXSUPPORT, PATIENT POSITION29
CCXSupport, Patient Position26
KIDRESTRAINT, WHEELCHAIR, NON-PROTECTIVE18
FWZOperating Room Accessories Table Tray11

GMDN & GCC registration

  • GMDN code 44851 · non‑implantable
  • Single‑use 55% · sterile 6% · Rx‑only 70% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 18Length (Millimeter) · 12Width (Millimeter) · 9Width (Inch) · 3Length (Meter) · 3Length (Feet) · 2

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

How many limb/torso/head restraint, single-use products are registered in the US?

491 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Limb/torso/head restraint, single-use", from 38 companies. The largest labeler is Deroyal Industries, Inc. with 48% of records.

Which FDA product codes apply?

FMQ (Restraint, protective), FMQ (Restraint, Protective), CCX (SUPPORT, PATIENT POSITION), CCX (Support, Patient Position)

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.

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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.

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