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Device Explorer · FDA GUDID · GMDN 47478

Alternating-pressure bed mattress overlay system

An assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfo

US‑registered devices1,510in commercial distribution
Companies31labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Span-America Medical Systems, Inc.22715%
Hill-Rom, Inc.20814%
Tridien Medical17412%
Kap Medical16311%
Carilex Medical, Inc.16111%
Arjohuntleigh Ab966%
Invacare Corporation835%
Proactive Medical Products, Llc695%

Top labelers

CompanyDevicesShare
Span-America Medical Systems, Inc.22715%
Hill-Rom, Inc.20814%
Tridien Medical17412%
Kap Medical16311%
Carilex Medical, Inc.16111%
Arjohuntleigh Ab966%
Invacare Corporation835%
Proactive Medical Products, Llc695%
L I N E T Spol. S R.O.513%
Drive Devilbiss Healthcare483%
Joerns Healthcare, Llc443%
New Source Medical, Llc332%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

IsoAirIsoTourSPECIALTYCostcareDALTONProtekt AireProtekt Supreme SupportREMEDIUMProtekt 1st DefenseSATIN-AIR BARIATRICProtekt Aire Replacement PumpProtekt Aire Replacement MattressAtmosAir VelarisCaylisAuralisAlpha Trancell Deluxe

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 Pressure1,156
IOQBED, FLOTATION THERAPY, POWERED213
FNMMATTRESS, AIR FLOTATION, ALTERNATING PRESSURE118
FNLBED, AC-POWERED ADJUSTABLE HOSPITAL107
IOQBed, Flotation Therapy, Powered64
OSIBariatric bed44

GMDN & GCC registration

  • GMDN code 47478 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 1% · OTC 26%
  • 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) · 92Width (Inch) · 92Height (Inch) · 82Length (Feet) · 5Weight (Pound) · 5

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

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

1,510 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Alternating-pressure bed mattress overlay system", from 31 companies. The largest labeler is Span-America Medical Systems, Inc. with 15% of records.

Which FDA product codes apply?

FNM (Mattress, Air Flotation, Alternating Pressure), IOQ (BED, FLOTATION THERAPY, POWERED), FNM (MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE), FNL (BED, AC-POWERED ADJUSTABLE HOSPITAL)

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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