Bed, Therapeutic, Ac-Powered, Adjustable Home-Use

FDA product code LLI · Class II (moderate risk) · 21 CFR 880.5100 · General Hospital

2510(k) clearances
0PMA approvals
17recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K022387Craftmatic Adjustable Beds with Optional Heat & Massage, Models Craftmatic Monaco, I…LLI · Traditional Craftmatic Organization, Inc.09/19/2002SE
K840787Craftmatic Electric Adjustable BedLLI · Traditional Contour, Inc.06/13/1984SE

Recalls

RecallProductFirmInitiated
Z-1016-2026 Class IMEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LOMedline Industries has identified a potential hazard involving the hand control pendant and associated… Medline Industries, LP11/26/2025Open, Classified
Z-1015-2026 Class IMEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003LMedline Industries has identified a potential hazard involving the hand control pendant and associated… Medline Industries, LP11/26/2025Open, Classified
Z-1014-2026 Class IMEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELOMedline Industries has identified a potential hazard involving the hand control pendant and associated… Medline Industries, LP11/26/2025Open, Classified
Z-1013-2026 Class IMEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full…Medline Industries has identified a potential hazard involving the hand control pendant and associated… Medline Industries, LP11/26/2025Open, Classified
Z-1012-2026 Class IMEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002LMedline Industries has identified a potential hazard involving the hand control pendant and associated… Medline Industries, LP11/26/2025Open, Classified
Z-1011-2026 Class IMEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi…Medline Industries has identified a potential hazard involving the hand control pendant and associated… Medline Industries, LP11/26/2025Open, Classified
Z-1251-2024 Class IIInvacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model…Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld… Invacare Corporation01/22/2024Open, Classified
Z-0329-2025 Class IISafeControl handset (a component of the Sentida bed which moves and positions the bed)…When the handset is disconnected from the power mains, and mains operation is restored, the handset is reset… Wissner-Bosserhoff GmbH07/11/2022Open, Classified
Z-1500-2022 Class IILegacy Base for Dual Bed ConfigurationsA potential for dual-configured beds to separate or slip away from one another. Craftmatic Industries, Inc.03/24/2017Open, Classified
Z-1499-2022 Class IICraftmatic Model 1 Base for Dual Bed ConfigurationsA potential for dual-configured beds to separate or slip away from one another. Craftmatic Industries, Inc.03/24/2017Open, Classified
Z-1185-2017 Class IIJunction Box - 1104343 and 1193560A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result… Invacare Corporation12/02/2016Terminated
Z-1184-2017 Class IIFoot Section - BAR5490IVCA quality issue with the junction box used in the bariatric bed junction that may omit sparks and result… Invacare Corporation12/02/2016Terminated
Z-1183-2017 Class IIBariatric Bed - BARPKG-IVC 1633A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result… Invacare Corporation12/02/2016Terminated
Z-1182-2017 Class IIBariatric Bed - BAR600IVCThe junction box used in the bariatric bed may emit sparks and result in a fire. Invacare Corporation12/02/2016Terminated
Z-1536-2012 LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Plastic Panels, Item…GF Health Products, Inc., is conducting a recall on the Lumex Patriot Full Electric Homecare "Bed Ends"… GF Health Products, Inc./d.b.a.Basic…04/17/2012Terminated
Z-0187-2012 Invacare 600 lb. Bariatric Bed, Head motor extension cable used on component numbers…Invacare Corporation decided to recall the products because risk analysis reveals that miskeying or… Invacare Corporation06/23/2011Terminated
Z-0063-2007 AC-powered Adjustable Hospital Bed. (ICCG Bed) Affected Model numbers: IH820-3MDLX…The incorrect caution label that describes washing instructions was applied to beds distributed in the US… Invacare Corporation09/27/2006Terminated