Device Explorer · FDA GUDID · GMDN 63237

Foam bed mattress

A large, durable, fabric case filled with foam, which may be segmented/compartmentalised, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body w

US‑registered devices666in commercial distribution
Companies15labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Span-America Medical Systems, Inc.47671%
Joerns Healthcare, Llc7311%
Thomas Hilfen Für Körperbehinderte Gmbh & Co. Medico Kommanditgesellschaft376%
Immersus Health Company, Llc183%
Dynarex Corporation142%
Accora Limited122%
Sizewise Rentals, L.L.C.102%
Invacare Corporation102%

Top labelers

CompanyDevicesShare
Span-America Medical Systems, Inc.47671%
Joerns Healthcare, Llc7311%
Thomas Hilfen Für Körperbehinderte Gmbh & Co. Medico Kommanditgesellschaft376%
Immersus Health Company, Llc183%
Dynarex Corporation142%
Accora Limited122%
Sizewise Rentals, L.L.C.102%
Invacare Corporation102%
Drive Devilbiss Healthcare51%
Umano Medical Inc41%
Kreg Medical Inc.30%
Philipcare Medical Manufacturing Inc.10%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Accora Allevia ClassicAccora Allevia PrimaAccora Allevia ComfortAdvantage"ThevoautoActive FR 297 lbs, Split King 38x79"","ThevoautoActiv FR 110 lbs, Split King 38x79"", "ThevoautoActiv FR 297 lbs, Hospital size 36x79""ThevoVital FR 308 lbs, Twin size 39x75"", jerseThevoautoActiv FR 297 lbs, Hospital size 36x79”,ThevoautoActiv FR 220 lbs, Hospital size 36x79”,"ThevoVital FR 308 lbs, Hospital size 36x79"", j"ThevoautoActiv FR 297 lbs, Split King 38x79"", "ThevoautoActiv FR 220 lbs, Split King 38x79"", "ThevoautoActiv FR 110 lbs, Split king 37x79"", "ThevoautoActiv FR 220 lbs, Queen size 60x79"", "ThevoautoActiv FR 110 lbs, Queen size 60x79"",

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

FDA product codes

CodeNameDevices
IKYMattress, Flotation Therapy, Non-Powered742
FMRDevice, Transfer, Patient, Manual10
FNMMattress, Air Flotation, Alternating Pressure3
KICCushion, Flotation2
FNMMATTRESS, AIR FLOTATION, ALTERNATING PRESSURE1
IKXAid, Transfer1

GMDN & GCC registration

  • GMDN code 63237 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 0% · OTC 30%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Height (Inch) · 1Length (Inch) · 1Width (Inch) · 1

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

How many foam bed mattress products are registered in the US?

666 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Foam bed mattress", from 15 companies. The largest labeler is Span-America Medical Systems, Inc. with 71% of records.

Which FDA product codes apply?

IKY (Mattress, Flotation Therapy, Non-Powered), FMR (Device, Transfer, Patient, Manual), FNM (Mattress, Air Flotation, Alternating Pressure), KIC (Cushion, Flotation)

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?

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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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