Product Code: FNL FDA class 2 21 CFR 880.5100

Bed, Ac-Powered Adjustable Hospital

General Hospital

The AC-Powered Adjustable Hospital Bed is an electrically powered hospital bed that allows motorized adjustment of head, foot, and height positions to optimize patient comfort and facilitate nursing care. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FNL, regulated under 21 CFR 880.5100 in the General Hospital specialty.

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510(k)s

FEI Numbers

228

Registration Numbers

228

Unique Applicants

Years Active

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Basic Information

Product Code: FNL
Device Class: FDA class 2
Regulation Number: 880.5100
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 70 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K202964	iBed Wireless with iBed Mobile	Jun 18, 2021	Substantially Equivalent	Stryker Corporation
K103536	IBED WIRELESS WITH IBED AWARENESS	Dec 16, 2010	Substantially Equivalent	Stryker Corporation
K982783	VAIL 1000 ENCLOSED BED	Oct 05, 1998	Substantially Equivalent	Vail Products, Inc.
K974296	MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED	Jan 06, 1998	Substantially Equivalent	Invacare Corp.
K974254	BENEFIT B3--- SERIES	Dec 16, 1997	Substantially Equivalent	M.C. Healthcare Products, Inc.
K972115	VOLKER HOSPITAL BED, MODEL K960	Aug 29, 1997	Substantially Equivalent	Volker Healthcare, Inc.
K971546	SOMA 900 TRANSPORT BED	Jul 10, 1997	Substantially Equivalent	Nova Technologies, Inc.
K963622	VAIL 2000 ENCLOSED BED	May 07, 1997	Substantially Equivalent	Vail Products, Inc.
K963589	VAIL 3000 BED ENCLOSURE	Apr 21, 1997	Substantially Equivalent	Vail Products, Inc.
K962942	TOTALCARE	Feb 03, 1997	Substantially Equivalent	Hill-Rom, Inc.
K963701	SOMA SAFE ENCLOSURE	Jan 24, 1997	Substantially Equivalent	Nova Technology Corp.
K964246	NOVABED PATIENT TRANSFER SYSTEM	Jan 22, 1997	Substantially Equivalent	Nova Technology Corp.
K964515	ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002	Dec 31, 1996	Substantially Equivalent	M.C. Healthcare Products, Inc.
K962250	CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED	Oct 21, 1996	Substantially Equivalent	Carroll Healthcare, Inc.
K962763	2000 MODULAR THIRTY-NINE	Oct 07, 1996	Substantially Equivalent	Equi-Tron Mfg., Inc.
K951514	SSC MODEL 4000 SERIES	Mar 06, 1996	Substantially Equivalent	Ssc Medical Products, Inc.
K951735	JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL	Aug 18, 1995	Substantially Equivalent	Joerns Healthcare, Inc.
K951161	MC ACCLAIM Q6000 BED	May 09, 1995	Substantially Equivalent	Janco Consulting Services
K945042	ELITE 3 LOW AIR LOSS BED	Mar 16, 1995	Substantially Equivalent	Pegabus Egerton, Ltd.
K946208	VOLKER NURSING BED MODEL 2080E & 2090E	Mar 14, 1995	Substantially Equivalent	Volker Healthcare, Inc.
K946149	STRYKER AGILITY INTENSIVE CARE BED	Mar 14, 1995	Substantially Equivalent	Stryker Medical
K945664	BARIKARE PLUS	Feb 16, 1995	Substantially Equivalent	Kinetic Concepts, Inc.
K935837	AIRHYTHM HEALTHCARE BED	Jun 21, 1994	Substantially Equivalent	Healthcare Designs
K934090	S.S.C. MEDICAL MODEL 5000 SERIES BED	Feb 09, 1994	Substantially Equivalent	Super Sagless Corp.
K932663	MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES	Nov 30, 1993	Substantially Equivalent	Medline Industries, Inc.
K930703	ADJUSTABLE BED	Nov 22, 1993	Substantially Equivalent	Maxwell Products, Inc.
K931581	GLENN BED	Oct 21, 1993	Substantially Equivalent	Kinetic Concepts, Inc.
K931482	STRYKER MPS ACUTE CARE BED	Sep 09, 1993	Substantially Equivalent	Stryker Corp.
K926435	COMFORTADE	Aug 19, 1993	Substantially Equivalent	Sensible Products
K930234	FLH1768M SERIES HOSPITAL BED	Jul 27, 1993	Substantially Equivalent	Bertec Medical, Inc.
K925576	BURKE BARIATRIC TREATMENT SYSTEM II	Jun 04, 1993	Substantially Equivalent	Burke Mobility Products
K925534	FULL/SEMI ELECTRIC HOME CARE BED	May 12, 1993	Substantially Equivalent	Ivacare Corp.
K922352	THE ADVANCE SERIES FROM HILL-ROM	Oct 13, 1992	Substantially Equivalent	Hill-Rom, Inc.
K915437	CRITICAL CARE HOSPITAL BED (ICU/CCU)	Jun 11, 1992	Substantially Equivalent	Hill-Rom, Inc.
K911893	EASY ACCESS BED	Nov 22, 1991	Substantially Equivalent	Willis Therapeutic Innovations, Inc.
K903904	SERIES 2000 ADJUSTABLE BED	Oct 12, 1990	Substantially Equivalent	Equi-Tron Mfg., Inc.
K902183	S.S.C. MEDICAL PRODUCTS HOME HEALTH CARE BED	Jul 11, 1990	Substantially Equivalent	Super Sagless Corp.
K900151	INVACARE EXTENDED CARE NURSING HOME BED	Jun 18, 1990	Substantially Equivalent	Invacare Corp.
K894296	PREMISE SERIES BED	Sep 22, 1989	Substantially Equivalent	Batesville American Mfg. Co.
K893745	THE INDEPENDENT CARE UNIT	Sep 22, 1989	Substantially Equivalent	The Water Carriage Co., Inc.
K890845	PREMISE SERIES BED	Jun 15, 1989	Substantially Equivalent	Batesville American Mfg. Co.
K890293	AIDE-A-PATIENT (NURSING HOME BED)	Apr 07, 1989	Substantially Equivalent	Morton Metalcraft Co.
K890426	CONSUMMATE AIR THERAPY BED	Apr 05, 1989	Substantially Equivalent	Health Products, Inc.
K881960	MSI STANDARD BED MODELS L1098-84/L1098-74/L1085-74	Nov 01, 1988	Substantially Equivalent	Med Service, Inc.
K883463	HOSPITAL BED CLOTHING CRADLE	Sep 19, 1988	Substantially Equivalent	Commercial Products & Engineering Co.
K881844	MAGNUM 800(TM) MANAGEMENT SYSTEM	Jul 14, 1988	Substantially Equivalent	The Medical Group, Inc.
K881782	MSI 4000 SERIES BED	Jul 12, 1988	Substantially Equivalent	Med Service, Inc.
K881963	MSI 3002 SERIES BED	Jun 28, 1988	Substantially Equivalent	Med Service, Inc.
K881965	MSI 5000 SERIES BED	May 31, 1988	Substantially Equivalent	Med Service, Inc.
K881027	MSI 2002 SERIES BED	May 26, 1988	Substantially Equivalent	Med Service, Inc.
K875037	STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED	Feb 11, 1988	Substantially Equivalent	Stryker Corp.
K873291	MSI 9000 SERIES BED	Dec 30, 1987	Substantially Equivalent	Med Service, Inc.
K872923	PARAGON 9000 TILT AND TURN BED	Oct 14, 1987	Substantially Equivalent	Surgi-Med, Inc.
K872924	PARAGON 8500 CARDIO-PULMONARY BED	Oct 09, 1987	Substantially Equivalent	Surgi-Med, Inc.
K872925	MEGABED 1000	Sep 15, 1987	Substantially Equivalent	Surgi-Med, Inc.
K864186	HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT)	Nov 13, 1986	Substantially Equivalent	Hill-Rom, Inc.
K864172	HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS	Nov 13, 1986	Substantially Equivalent	Hill-Rom, Inc.
K854937	CARROM CARELIFE SERIES 40000 MODULAR BES SYSTEM	Feb 04, 1986	Substantially Equivalent	Carrom Healthcare, Inc.
K854867	EVEREST & JENNINGS TRADITION-STANDARD BED L109684&	Feb 04, 1986	Substantially Equivalent	Carrom Healthcare, Inc.
K854832	EVEREST & JENNING SERIES 5000 MODULAR BED	Feb 04, 1986	Substantially Equivalent	Carrom Healthcare, Inc.
K853270	CENTERCOM CONTROL	Nov 13, 1985	Substantially Equivalent	Carrom Healthcare, Inc.
K852674	STRYKER 988 ICU BED	Jul 16, 1985	Substantially Equivalent	Stryker Corp.
K851551	MERIVAARA ELECTRIC HOSPITAL BED & ACCESSORIES	May 08, 1985	Substantially Equivalent	Daun International, Inc.
K843781	KINAIR, LOW AIR LOSS BED	Jan 28, 1985	Substantially Equivalent	Kinetic Concepts, Inc.
K831821	PNEUMATIC/ELECTRIC/HYDRAULIC BED	Aug 08, 1983	Substantially Equivalent	G.W. Healthcare, Inc.
K830559	HEALTHCARE MODEL #175/176 BED SERIES	Mar 09, 1983	Substantially Equivalent	G.W. Healthcare, Inc.
K821185	NEW SUPPORT SYS. FOR BEDRIDDEN PATIENTS	Sep 14, 1982	Substantially Equivalent	Dase Co.
K811897	LIC TURNOVER BED	Jul 28, 1981	Substantially Equivalent	Century Manufacturing Co.
K790049	BED, PARAPLEGIC	Feb 27, 1979	Substantially Equivalent	Wayne V. Kirkman
K780371	TILT TYPE AC POWERED HOSPITAL BED	Apr 10, 1978	Substantially Equivalent	Medical Specialty Products, Inc.