Consulting Wallah › Device Explorer › Other devices › Inflatable extremity splint, reusable
Device Explorer · FDA GUDID · GMDN 32302

Inflatable extremity splint, reusable

A sleeve intended to be placed around an arm or leg and inflated to immobilize and protect the limb following injury. It is typically used by emergency medical services (EMS) as a temporary measure in emergencies to stabilize the limb for transport to a hospit

US‑registered devices58in commercial distribution
Companies5labelers on GUDID
Single‑use84%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Darco International, Inc.3153%
Darco (Europe) Gmbh1017%
Allied Medical, Llc916%
Acme United Corporation610%
Mueller Sports Medicine, Inc.23%

Top labelers

CompanyDevicesShare
Darco International, Inc.3153%
Darco (Europe) Gmbh1017%
Allied Medical, Llc916%
Acme United Corporation610%
Mueller Sports Medicine, Inc.23%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Body Armor® PFA Walker LinerBody Armor® PFA Walker LinerBody Armor® PFA WalkerBody Armor® PFA WalkerDARCO® AirTraveler™ Walker LinerDARCO® AirTraveler™ WalkerDARCO® Toe PlateDARCO® Body Armor® Night SplintDARCO® Night SplintDARCO® Body Armor® Pro TermDARCO® Body Armor® ProTermDARCO® Body Armor® Pro Term LinerFirst Aid OnlyMueller Aircast Ankle Brace Right WhiteMueller Aircast Ankle Brace Left WhiteSC

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

FDA product codes

CodeNameDevices
FZFSPLINT, EXTREMITY, INFLATABLE, EXTERNAL30
FZFSplint, Extremity, Inflatable, External11
FYHSplint, Extremity, Noninflatable, External, Sterile9
NOCSplint, extremity, non-inflatable, external, non-sterile7
NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile3

GMDN & GCC registration

  • GMDN code 32302 · non‑implantable
  • Single‑use 84% · sterile 0% · Rx‑only 0% · OTC 14%
  • 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 inflatable extremity splint, reusable products are registered in the US?

58 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Inflatable extremity splint, reusable", from 5 companies. The largest labeler is Darco International, Inc. with 53% of records.

Which FDA product codes apply?

FZF (SPLINT, EXTREMITY, INFLATABLE, EXTERNAL), FZF (Splint, Extremity, Inflatable, External), FYH (Splint, Extremity, Noninflatable, External, Sterile), NOC (Splint, extremity, non-inflatable, external, non-sterile)

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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