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Device Explorer · FDA GUDID · GMDN 63241

Alternating-pressure bed mattress system

An assembly of devices consisting of an alternating-pressure bed mattress (inflation-patterned air cells with or without foam component) and a dedicated electric pump, which also functions as the control unit, designed to actively alternate a bed occupant's be

US‑registered devices556in commercial distribution
Companies20labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Span-America Medical Systems, Inc.29854%
Sizewise Rentals, L.L.C.6512%
Wellell Inc.489%
Foshan Hongfeng Co., Ltd.407%
Caremed Supply Inc.356%
Medline Industries, Inc.143%
Thin Air Surfaces, Llc92%
Nu Dimension Tech Ventures Llc92%

Top labelers

CompanyDevicesShare
Span-America Medical Systems, Inc.29854%
Sizewise Rentals, L.L.C.6512%
Wellell Inc.489%
Foshan Hongfeng Co., Ltd.407%
Caremed Supply Inc.356%
Medline Industries, Inc.143%
Thin Air Surfaces, Llc92%
Nu Dimension Tech Ventures Llc92%
Joerns Healthcare, Llc81%
Hangzhou Guoyuan Yanglao Technology Co., Ltd61%
Levisense Medical, Inc.61%
Vive Health Llc51%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

InhwRiorVOCICbtecareFOFOMOVFRIAccora Allevia DuoAccora Allevia SenseWellellAPEXGreat LifePrius Healthcare USAPRIUSUnisoftThinAIRClinicare Hybrid 3000 Mattress w/ Micro Climate Clinicare Active Mattress w/ Micro Climate Manag

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

FDA product codes

CodeNameDevices
FNMMattress, Air Flotation, Alternating Pressure493
FMRDevice, Transfer, Patient, Manual64
FNMMATTRESS, AIR FLOTATION, ALTERNATING PRESSURE13
IOQBed, Flotation Therapy, Powered4
FNMMattress, air flotation, alternating pressure1
IKYMattress, Flotation Therapy, Non-Powered1

GMDN & GCC registration

  • GMDN code 63241 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 0% · OTC 17%
  • 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) · 7Width (Inch) · 6

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

How many alternating-pressure bed mattress system products are registered in the US?

556 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Alternating-pressure bed mattress system", from 20 companies. The largest labeler is Span-America Medical Systems, Inc. with 54% of records.

Which FDA product codes apply?

FNM (Mattress, Air Flotation, Alternating Pressure), FMR (Device, Transfer, Patient, Manual), FNM (MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE), IOQ (Bed, Flotation Therapy, Powered)

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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