Device Explorer · FDA GUDID · GMDN 17593

Low-air-loss bed

A mains electricity (AC-powered) bed that permits a controlled release of air through its dedicated mattress and is used for tissue pressure management during patient confinement in a hospital acute care department and nursing homes. The device consists of a m

US‑registered devices1,263in commercial distribution
Companies18labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Kap Medical99379%
Moxi Enterprises, Llc746%
Medline Industries, Inc.323%
Tridien Medical272%
Invacare Corporation242%
Umano Medical Inc222%
Joerns Healthcare, Llc181%
Span-America Medical Systems, Inc.181%

Top labelers

CompanyDevicesShare
Kap Medical99379%
Moxi Enterprises, Llc746%
Medline Industries, Inc.323%
Tridien Medical272%
Invacare Corporation242%
Umano Medical Inc222%
Joerns Healthcare, Llc181%
Span-America Medical Systems, Inc.181%
Medacure Inc.151%
Emerald Supplies Inc131%
James Consolidated, Inc.71%
Kreg Medical Inc.60%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SPR PlusMaxxAirFirstStep SelectFIRST STEP CIRRUSMEDACURETHE KREG INTEGRATED ALTERNATING MATTRESS SYSTEMTHE KREG INTEGRATED CLRT MATTRESS SYSTEMDolphin Fluid Immersion SimulationDolphin FISDolphin Pediatric Fluid Immersion SimulationFreedom Wave IIThe Völkner® Turning SystemAP MAX MATTRESS SYSTEMStryker AirHill-RomINVACARE® MICROAIR® THERAPEUTIC SUPPORT SURFACE

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 Pressure808
IKZBed, Patient Rotation, Powered243
IOQBed, Flotation Therapy, Powered177
FNMMattress, air flotation, alternating pressure32
FNMMATTRESS, AIR FLOTATION, ALTERNATING PRESSURE17
IKYMattress, Flotation Therapy, Non-Powered2

GMDN & GCC registration

  • GMDN code 17593 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 1% · OTC 4%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Pound) · 13

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

How many low-air-loss bed products are registered in the US?

1,263 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Low-air-loss bed", from 18 companies. The largest labeler is Kap Medical with 79% of records.

Which FDA product codes apply?

FNM (Mattress, Air Flotation, Alternating Pressure), IKZ (Bed, Patient Rotation, Powered), IOQ (Bed, Flotation Therapy, Powered), 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.

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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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