Product Code: FNJ FDA class 1 21 CFR 880.5120

Bed, Manual

General Hospital

The Manual Hospital Bed is a non-powered adjustable bed designed for inpatient use, with position adjustments made by manual cranks to support patient positioning, comfort, and care access. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FNJ, regulated under 21 CFR 880.5120 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.

View on FDA

510(k)s

FEI Numbers

221

Registration Numbers

221

Unique Applicants

Years Active

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Basic Information

Product Code: FNJ
Device Class: FDA class 1
Regulation Number: 880.5120
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 39 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K934298	KING KRIB	Jan 26, 1994	Substantially Equivalent	Noritage, Inc.
K892877	CRADLE, HOSPITAL BED CLOTHING	Jun 15, 1989	Substantially Equivalent	Warsaw Orthopedic, Inc.
K885241	BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT	Feb 24, 1989	Substantially Equivalent	King Mfg. Co.
K884542	SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED	Nov 21, 1988	Substantially Equivalent	Commercial Products & Engineering Co.
K881725	ENVIROTENT (BED)	Nov 08, 1988	Substantially Equivalent	Envirotents, Inc.
K881961	MSI STANDARD BED MODELS: L1097-64 AND L1085-64	Nov 01, 1988	Substantially Equivalent	Med Service, Inc.
K881964	MSI 3003 SERIES BED	Jun 28, 1988	Substantially Equivalent	Med Service, Inc.
K881962	MSI 2005 SERIES BED	Jun 03, 1988	Substantially Equivalent	Med Service, Inc.
K881043	FOLDING HOSPITAL COT NSN 6530-00-299-8517	Apr 12, 1988	Substantially Equivalent	Junkin Safety Appliance Co., Inc.
K870166	PLATFORM MATTRESS W/DISPOSABLE BEDPAN BAG	Mar 13, 1987	Substantially Equivalent	George C. Kuhn
K870310	VSID MEDICAL THREE-FOLDING BED	Feb 10, 1987	Substantially Equivalent	China National Medicines & Health Prod. I/E Corp.
K864667	PENOX HOSPITAL BED	Jan 21, 1987	Substantially Equivalent	Penox Technologies, Inc.
K863694	BED/ADJUST/HOSPITAL/FOLDING FIELD WITHOUT MATTRESS	Jan 20, 1987	Substantially Equivalent	Brenner Metal Prod Corp.
K863691	COT, FOLDING, HOSPITAL, ALUMINUM	Jan 20, 1987	Substantially Equivalent	Brenner Metal Prod Corp.
K863688	ROD, IRRIGATOR, SUPPORTING TELESCOPING, TYPE	Jan 20, 1987	Substantially Equivalent	Brenner Metal Prod Corp.
K863685	CART, ORTHOPEDIC BED, STRYKER	Jan 15, 1987	Substantially Equivalent	Brenner Metal Prod Corp.
K864878	ICU/CPU TRANSPORT TRAY	Jan 06, 1987	Substantially Equivalent	Orthopedic Systems, Inc.
K864203	NESBIT EVANS NURSING HOME BED	Nov 07, 1986	Substantially Equivalent	J. Nesbit Evans & Co.
K863748	HOSPITAL BED	Oct 09, 1986	Substantially Equivalent	Global Medical Prods, Inc.
K861678	COT, FOLDING HOSPITAL ALUMINUM - MANUAL BED	May 08, 1986	Substantially Equivalent	Sierra Corp.
K854940	TIPS AND PADS, CANE,CRUTCH AND WALKER	Jan 30, 1986	Substantially Equivalent	Healthtech Industries, Inc.
K854776	EVEREST & JENNINGS BED MODEL NO. L109564 & L108564	Dec 13, 1985	Substantially Equivalent	Carrom Healthcare, Inc.
K854257	COMBO 36	Nov 18, 1985	Substantially Equivalent	Kg Engineering, Inc.
K852890	AM FAB SIDE RAILS MODEL 5000	Jul 24, 1985	Substantially Equivalent	Am Fab, Inc.
K851552	MERIVAARA HOSPITAL BED	May 08, 1985	Substantially Equivalent	Daun International, Inc.
K840653	BERNIER ARM SUPPORT	Mar 19, 1984	Substantially Equivalent	T.C. Toll Corp.
K832845	EGERTON TURNING & TILTING NET SUSPEN BED	Nov 28, 1983	Substantially Equivalent	Kinetic Concepts, Inc.
K823821	SIDE RAIL PADS	Jan 21, 1983	Substantially Equivalent	Danek Medical, Inc.
K813356	DEVICE FOR REPOSITIONING A BET PATIENT	Feb 10, 1982	Substantially Equivalent	Ali-Oop Co., Inc.
K812600	GER 540, GER 541 MANUAL BED	Sep 23, 1981	Substantially Equivalent	G.W. Healthcare, Inc.
K810846	SWEEN UNIVERSAL BED RAIL PADS	Apr 17, 1981	Substantially Equivalent	Sween Corp.
K801517	BED ROCKING DEVICE	Oct 10, 1980	Substantially Equivalent	Wesler
K792298	THE VERSA-BED	Dec 20, 1979	Substantially Equivalent	First & Ten, Inc.
K791993	SKIL-CARE BED RAIL PADS	Oct 26, 1979	Substantially Equivalent	Skil-Care Corp.
K791189	ECHO CARDIOGRAM PAD	Jul 17, 1979	Substantially Equivalent	Alimed, Inc.
K772262	TRAPEZE BAR KNOCKED DOWN	Jan 26, 1978	Substantially Equivalent	Med Fusion Systems, Inc.
K772261	TRAPEZE FLOOR BASE	Jan 26, 1978	Substantially Equivalent	Med Fusion Systems, Inc.
K772260	TELESCOPING BEDRAILS	Jan 26, 1978	Substantially Equivalent	Med Fusion Systems, Inc.
K760315	PAD, POLYETHER FOAM, OPEN CELL	Aug 11, 1976	Substantially Equivalent	Gaymar Industries, Inc.