Device Explorer · FDA GUDID · GMDN 60422

Gel-filled bed mattress

A large, durable, fabric case filled with various densities of foam that support a gel structure, 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 distribut

US‑registered devices51in commercial distribution
Companies4labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Drive Devilbiss Healthcare2447%
Stryker Corporation1835%
Joerns Healthcare, Llc612%
Dynarex Corporation36%

Top labelers

CompanyDevicesShare
Drive Devilbiss Healthcare2447%
Stryker Corporation1835%
Joerns Healthcare, Llc612%
Dynarex Corporation36%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

IsoTourPower-LOADNAIsoFlex LALDriveDRIVEMEDICALGel FoamDynaRest Premium Visco-Gel Infused Foam Mattress

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-POWERED34
IOQBED, FLOTATION THERAPY, POWERED12
IKYMattress, Flotation Therapy, Non-Powered9
FMWCOVER, MATTRESS (MEDICAL PURPOSES)5
FNMMATTRESS, AIR FLOTATION, ALTERNATING PRESSURE4
FPOSTRETCHER, WHEELED1

GMDN & GCC registration

  • GMDN code 60422 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 0% · OTC 6%
  • 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 gel-filled bed mattress products are registered in the US?

51 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Gel-filled bed mattress", from 4 companies. The largest labeler is Drive Devilbiss Healthcare with 47% of records.

Which FDA product codes apply?

IKY (MATTRESS, FLOTATION THERAPY, NON-POWERED), IOQ (BED, FLOTATION THERAPY, POWERED), IKY (Mattress, Flotation Therapy, Non-Powered), FMW (COVER, MATTRESS (MEDICAL PURPOSES))

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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