Device Explorer · FDA GUDID · GMDN 47520

Orthopaedic bed mattress

A large, durable, fabric case filled with a combination of layered resilient materials (e.g., foam rubber and gel) designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep, and to pro

US‑registered devices155in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Thomas Hilfen Für Körperbehinderte Gmbh & Co. Medico Kommanditgesellschaft13386%
Moxi Enterprises, Llc128%
Curbell Medical Products, Inc.85%
Burke, Inc.11%
Medline Industries, Inc.11%

Top labelers

CompanyDevicesShare
Thomas Hilfen Für Körperbehinderte Gmbh & Co. Medico Kommanditgesellschaft13386%
Moxi Enterprises, Llc128%
Curbell Medical Products, Inc.85%
Burke, Inc.11%
Medline Industries, Inc.11%

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

Brand names on the register (sample)

Thevo Flex FR 140kg, 105x200cm, jersey whiteThevoRelief FR 100 100x190 Inko, grey"ThevoRelief FR 220 lbs, 38 x 79"""" (Split King"ThevoCalm FR 179 lbs, Twin size 39x75"", inco g"ThevoRelief FR 297 lbs, Hospital size 36x79"", "ThevoRelief FR 220 lbs, Hospital size 36x79"", "ThevoCalm FR 308 lbs, Hospital size 36x79"", in"ThevoVital FR 308 lbs, Split King 36x79"", inco"ThevoVital FR 176 lbs, Split King 36x79"", inco"ThevoCalm FR 308 lbs, Split King 38x79"", inco "ThevoSleepingStar FR 132 Ibs, Twin size 39x75"""ThevoFlex FR 176 lbs, Split Queen 30x79"", jers"ThevoVital FR 308 lbs, Queen size 60x79"", jersThevoFlex FR 308 lbs, Twin size 39x75”, jersey w"ThevoFlex FR 176 lbs, Twin size 39x75"", jerseyThevoRelief FR 297 lbs, Twin size 39x75”, jersey

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-Powered164
ILSAdaptor, Hygiene1
FNMMATTRESS, AIR FLOTATION, ALTERNATING PRESSURE1

GMDN & GCC registration

  • GMDN code 47520 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 0% · OTC 1%
  • 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 orthopaedic bed mattress products are registered in the US?

155 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bed mattress", from 5 companies. The largest labeler is Thomas Hilfen Für Körperbehinderte Gmbh & Co. Medico Kommanditgesellschaft with 86% of records.

Which FDA product codes apply?

IKY (Mattress, Flotation Therapy, Non-Powered), ILS (Adaptor, Hygiene), FNM (MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE)

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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