Consulting Wallah › Device Explorer › Mobility, beds & patient care › Foam-filled bed mattress overlay
Device Explorer · FDA GUDID · GMDN 42328

Foam-filled bed mattress overlay

A foam-filled pad or thin mattress, usually full-body length, which is placed on top of a bed mattress to distribute an occupant's body weight over a large surface area, typically to relieve pressure points for comfort and to prevent pressure sores. It is comm

US‑registered devices126in commercial distribution
Companies7labelers on GUDID
Single‑use55%of device records
Sterile0%labelled sterile
Prescription2%Rx‑only share
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Share of device records

Cardinal Health, Inc.7660%
Arjohuntleigh Ab3729%
Drive Devilbiss Healthcare97%
Hangzhou A-Tek Medical & Textiles Co., Ltd.11%
Hill-Rom, Inc.11%
Alimed, Inc.11%
Covidien Lp11%

Top labelers

CompanyDevicesShare
Cardinal Health, Inc.7660%
Arjohuntleigh Ab3729%
Drive Devilbiss Healthcare97%
Hangzhou A-Tek Medical & Textiles Co., Ltd.11%
Hill-Rom, Inc.11%
Alimed, Inc.11%
Covidien Lp11%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DISPOSABLE BEDDING PRODUCTSTherarestAtmosAir 9000XPentaflexConformXSimulflexRIKCOMFORT PAD ASSEMBLYDRIVEMEDICALDriveBED PAD(203) KNIT COVERDevonEmprint SX

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

FDA product codes

CodeNameDevices
CCXSUPPORT, PATIENT POSITION74
IKYMattress, Flotation Therapy, Non-Powered42
FMWCOVER, MATTRESS (MEDICAL PURPOSES)11
FMPProtector, Skin Pressure6
KICCUSHION, FLOTATION3
IKYMATTRESS, FLOTATION THERAPY, NON-POWERED2

GMDN & GCC registration

  • GMDN code 42328 · non‑implantable
  • Single‑use 55% · sterile 0% · Rx‑only 2% · OTC 93%
  • 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) · 14Outer Diameter (Inch) · 11Width (Inch) · 10Height (Inch) · 10

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

No closely related category with 50+ devices.

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

126 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Foam-filled bed mattress overlay", from 7 companies. The largest labeler is Cardinal Health, Inc. with 60% of records.

Which FDA product codes apply?

CCX (SUPPORT, PATIENT POSITION), IKY (Mattress, Flotation Therapy, Non-Powered), FMW (COVER, MATTRESS (MEDICAL PURPOSES)), FMP (Protector, Skin 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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