FDA.reportPublic FDA data

Alternating-pressure bed mattress system

Definition
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 bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.
GUDID devices
560
Last updated
2026-10-06 03:49:38

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
H933M90068Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.EASY AIR LR2026-09-25
00810055885695DOLPHIN FIS 48X82X10 AUTOVECTOR SYSTEM UKJOERNS HEALTHCARE, LLCDLPH-4882OOUKJ-KIT2026-08-26
00810055885701SYSTEM, DLPH PEDIATRIC CRIB, UKJOERNS HEALTHCARE, LLCDLPP-2850CBUKJ-KIT2026-08-26
00810055885718DOLPHIN FIS 35X82X10 AUTOVECTOR SYSTEM UKJOERNS HEALTHCARE, LLCDLPH-3582OOUKJ-KIT2026-08-26
00810055885725SYSTEM, 33X82X10, DOLPHIN PEDIATRIC, UKJOERNS HEALTHCARE, LLCDLPP-3382OOUKJ-KIT2026-08-26
00810055885732DOLPHIN 33.5 X 82 AUTOVECTOR SYSTEMJOERNS HEALTHCARE, LLCDLPH-3382OOUKJ-KIT2026-08-26
00850076421106ThinAIRTHIN AIR SURFACES, LLCTAOR-43202-FS2026-07-31
00850076421113ThinAIRTHIN AIR SURFACES, LLCTAOR-43202-0C2026-07-31
00850076421120ThinAIRTHIN AIR SURFACES, LLCTAOR-18202-0F2026-07-31
00850076421137ThinAIRTHIN AIR SURFACES, LLCTAOR-10202-0H2026-07-31
H93359076Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.APM22026-07-27
00616784044514DynaRest Bariatric Plus Airfloat Air Mattress With Pump, 42"Dynarex Corporation104452018-05-23
00616784044613Bariatric Plus Airfloat Air Mattress With Pump 48"Dynarex Corporation104462018-05-23
00616784044712DynaRest Airfloat 500 With Digital Pump, 36" x 80" x 8"Dynarex Corporation104472019-03-18
00840117324701Dynarex Bari + Max Bariatric HD Airfloat Air Mattress with PumpDynarex Corporation104392022-11-01
G771PDA91003680Pro-Daptive SensorCell Flotation SurfaceLEVISENSE MEDICAL, INC.PDA-9100-36802026-06-09
04719893356922WellellWellell Inc.9P-0773712026-03-20
00810113572765Vive HealthVIVE HEALTH LLCLVA3019BGE2023-04-26
00810113573144ViveVIVE HEALTH LLCLVA3024BGE2023-08-02
00810113577081ViveVIVE HEALTH LLCLVA3058BLK2024-07-12
00818323029314ViveVIVE HEALTH LLCLVA2030BGE2023-08-02
04717677480023PRIUSCAREMED SUPPLY INC.FC-PHR00322016-11-25
04717677480030PRIUSCAREMED SUPPLY INC.FC-PHR00252016-11-25
04717677480047PRIUSCAREMED SUPPLY INC.FC-PHR00412016-11-25
04717677480450PRIUSCAREMED SUPPLY INC.FC-PHR00262024-01-09
04719893355970WellellWellell Inc.9P-0775202025-10-16
04719893356007WellellWellell Inc.9P-0775202025-10-16
04719893356021WellellWellell Inc.9P-0740002025-10-16
05056147701404Accora Allevia SenseACCORA LIMITEDAllevia Sense2025-09-30
05056147701428Accora Allevia DuoACCORA LIMITEDAllevia Duo2025-09-30
06975084517017btecareXIAMEN BEATLECARE ELECTRONIC TECHNOLOGY CO., LTDBA-2+BM250C2022-12-29
H93338036Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.APM-i2026-04-13
H93338042Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.APM-i2026-04-13
H93338436Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.APM-i2026-04-13
H93338442Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.APM-i2026-04-13
H93360787BF0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.PressureGaurd Custom Care NP2021-05-28
H93364565Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.PressureGuard APM22024-02-14
H93365077Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.PressureGuard APM22024-04-16
H93366914BF0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.PressureGaurd Custom Care NP2021-05-28
H93368413Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.PressureGaurd Custom Care NP2021-05-28
H93377563Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.PressureGaurd Custom Care NP2021-05-28
H93381129Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.PressureGaurd Easy Air LR2021-05-28
H93389193Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.PressureGaurd Easy Air LR2021-05-28
H93389193CEI0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.PressureGaurd Easy Air LR2021-05-28
H933LM7842XL29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.EASY AIR XL2022-05-18
H933M81129Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.PressureGaurd Easy Air LR2021-05-28
H933M89193Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.PressureGaurd Easy Air LR2021-05-28
H933PR13022Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.OSKA SPAN CARE2023-01-17
H933PR13051Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.OSKA APM22025-12-01
H933PR13444Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.OSKA SPAN CARE2023-01-17
H933PR13555Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.OSKA SPAN CARE2023-01-17
H933PR13601Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.OSKA APM22023-01-17
H933PR13606Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.OSKA APM22023-01-17
H933PR13607Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.OSKA APM22023-01-17
H933PR13613Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.OSKA SPAN CARE2023-01-17
H933PT85V0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.PRESTO2022-07-06
00860013391003ThinAIRTHIN AIR SURFACES, LLCTAOR-44202-FS2026-03-10
00860013391010ThinAIRTHIN AIR SURFACES, LLCTAOR-44202-0C2026-03-10
00860013391027ThinAIRTHIN AIR SURFACES, LLCTAOR-24202-0F2026-03-10
00860013391034ThinAIRTHIN AIR SURFACES, LLCTAOR-13202-0H2026-03-10
00860013391041ThinAIRTHIN AIR SURFACES, LLCTAC-101-0T2026-03-10
H93392270Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.Span Care Convertible2026-02-25
04719893356540WellellWellell Inc.9P-0770002026-02-11
00810178884483ViveVIVE HEALTH LLCLVA31122026-01-30
06978785665100InhwRiorShenzhen Yuechuan trade Co., Ltd.RCD2025-12-08
04719893355871WellellWellell Inc. 9P-0775202025-09-19
H93332864Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.CUSTOM CARE LAL2025-09-09
H93355696Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.CUSTOM CARE LAL2025-09-09
H93384683Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.CUSTOM CARE LAL2025-09-09
H93392474Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.CUSTOM CARE LAL2025-09-09
H93312335Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.Pressureguard APM II2021-05-28
04719893311877WellellWellell Inc.9P-0775202025-05-28
04719893311884WellellWellell Inc.9P-0770002025-05-28
04719893354690WellellWellell Inc.9P-0790002025-05-21
04719893354713WellellWellell Inc. 9P-0775202025-05-21
04719893354591WellellWellell Inc.9P-0770002025-04-30
04719893354621WellellWellell Inc. 9P-0775202025-04-30
04719893354652WellellWellell Inc.9P-0770002025-04-30
04719893354355WellellWellell Inc.9P-0873102025-04-08
04719893354386WellellWellell Inc.9P-0873302025-04-08