Bed, Manual
FDA product code FNJ · Class I (low risk) · 21 CFR 880.5120 · General Hospital
39510(k) clearances
0PMA approvals
6recalls
GMP exemptexempt from GMP rules
Manufacturers
- Brenner Metal Prod Corp. 4
- Med Fusion Systems, Inc. 3
- Med Service, Inc. 3
- Daun International, Inc. 1
- Gaymar Industries, Inc. 1
- Alimed, Inc. 1
- Global Medical Prods, Inc. 1
- Sierra Corp. 1
- Noritage, Inc. 1
- Carrom Healthcare, Inc. 1
- Kg Engineering, Inc. 1
- Am Fab, Inc. 1
- Skil-Care Corp. 1
- T.C. Toll Corp. 1
- Kinetic Concepts, Inc. 1
- Danek Medical, Inc. 1
- Ali-Oop Co., Inc. 1
- G.W. Healthcare, Inc. 1
- Sween Corp. 1
- Wesler 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K934298 | King KribFNJ · Traditional | Noritage, Inc. | 01/26/1994SE |
| K892877 | Cradle, Hospital Bed ClothingFNJ · Traditional | Warsaw Orthopedic, Inc. | 06/15/1989SE |
| K885241 | Bed, Adjustable, Hospital, Folding, Field, W/O MatFNJ · Traditional | King Mfg. Co. | 02/24/1989SE |
| K884542 | Sic 3999 Folding Adjustable Hospital BedFNJ · Traditional | Commercial Products & Engineering Co. | 11/21/1988SE |
| K881725 | Envirotent (Bed)FNJ · Traditional | Envirotents, Inc. | 11/08/1988SE |
| K881961 | Msi Standard Bed Models: L1097-64 and L1085-64FNJ · Traditional | Med Service, Inc. | 11/01/1988SE |
| K881964 | Msi 3003 Series BedFNJ · Traditional | Med Service, Inc. | 06/28/1988SE |
| K881962 | Msi 2005 Series BedFNJ · Traditional | Med Service, Inc. | 06/03/1988SE |
| K881043 | Folding Hospital Cot NSN 6530-00-299-8517FNJ · Traditional | Junkin Safety Appliance Co., Inc. | 04/12/1988SE |
| K870166 | Platform Mattress W/Disposable Bedpan BagFNJ · Traditional | George C. Kuhn | 03/13/1987SE |
| K870310 | Vsid Medical Three-Folding BedFNJ · Traditional | China National Medicines & Health Prod. I/E Corp. | 02/10/1987SE |
| K864667 | Penox Hospital BedFNJ · Traditional | Penox Technologies, Inc. | 01/21/1987SE |
| K863694 | Bed/Adjust/Hospital/Folding Field Without MattressFNJ · Traditional | Brenner Metal Prod Corp. | 01/20/1987SE |
| K863691 | Cot, Folding, Hospital, AluminumFNJ · Traditional | Brenner Metal Prod Corp. | 01/20/1987SE |
| K863688 | Rod, Irrigator, Supporting Telescoping, TypeFNJ · Traditional | Brenner Metal Prod Corp. | 01/20/1987SE |
| K863685 | Cart, Orthopedic Bed, StrykerFNJ · Traditional | Brenner Metal Prod Corp. | 01/15/1987SE |
| K864878 | Icu/Cpu Transport TrayFNJ · Traditional | Orthopedic Systems, Inc. | 01/06/1987SE |
| K864203 | Nesbit Evans Nursing Home BedFNJ · Traditional | J. Nesbit Evans & Co. | 11/07/1986SE |
| K863748 | Hospital BedFNJ · Traditional | Global Medical Prods, Inc. | 10/09/1986SE |
| K861678 | Cot, Folding Hospital Aluminum - Manual BedFNJ · Traditional | Sierra Corp. | 05/08/1986SE |
| K854940 | Tips and Pads, Cane,Crutch and WalkerFNJ · Traditional | Healthtech Industries, Inc. | 01/30/1986SE |
| K854776 | Everest & Jennings Bed Model No. L109564 & L108564FNJ · Traditional | Carrom Healthcare, Inc. | 12/13/1985SE |
| K854257 | Combo 36FNJ · Traditional | Kg Engineering, Inc. | 11/18/1985SE |
| K852890 | Am Fab Side Rails Model 5000FNJ · Traditional | Am Fab, Inc. | 07/24/1985SE |
| K851552 | Merivaara Hospital BedFNJ · Traditional | Daun International, Inc. | 05/08/1985SE |
| K840653 | Bernier Arm SupportFNJ · Traditional | T.C. Toll Corp. | 03/19/1984SE |
| K832845 | Egerton Turning & Tilting Net Suspen BedFNJ · Traditional | Kinetic Concepts, Inc. | 11/28/1983SE |
| K823821 | Side Rail PadsFNJ · Traditional | Danek Medical, Inc. | 01/21/1983SE |
| K813356 | Device for Repositioning a Bet PatientFNJ · Traditional | Ali-Oop Co., Inc. | 02/10/1982SE |
| K812600 | Ger 540, Ger 541 Manual BedFNJ · Traditional | G.W. Healthcare, Inc. | 09/23/1981SE |
| K810846 | Sween Universal Bed Rail PadsFNJ · Traditional | Sween Corp. | 04/17/1981SE |
| K801517 | Bed Rocking DeviceFNJ · Traditional | Wesler | 10/10/1980SE |
| K792298 | The Versa-BedFNJ · Traditional | First & Ten, Inc. | 12/20/1979SE |
| K791993 | Skil-Care Bed Rail PadsFNJ · Traditional | Skil-Care Corp. | 10/26/1979SE |
| K791189 | Echo Cardiogram PadFNJ · Traditional | Alimed, Inc. | 07/17/1979SE |
| K772262 | Trapeze Bar Knocked DownFNJ · Traditional | Med Fusion Systems, Inc. | 01/26/1978SE |
| K772261 | Trapeze Floor BaseFNJ · Traditional | Med Fusion Systems, Inc. | 01/26/1978SE |
| K772260 | Telescoping BedrailsFNJ · Traditional | Med Fusion Systems, Inc. | 01/26/1978SE |
| K760315 | Pad, Polyether Foam, Open CellFNJ · Traditional | Gaymar Industries, Inc. | 08/11/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1239-2022 Class II | Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCSThe warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but… | Oakworks Inc | 04/21/2022Terminated |
| Z-2343-2010 | Service parts for Crank Screw Assembly (PN1069-042-010S and 1069-042110S) Stryker…The fowler of the bed is raised by a crank. The crank consists of a steel screw that moves through a brass… | Stryker Medical Div. of Stryker Corporation | 02/26/2010Terminated |
| Z-2342-2010 | Eye surgery stretcher with crank fowler, model 1079 Stryker Medical 3800 E. Centre Ave…The fowler of the bed is raised by a crank. The crank consists of a steel screw that moves through a brass… | Stryker Medical Div. of Stryker Corporation | 02/26/2010Terminated |
| Z-2341-2010 | Eye surgery stretcher with crank fowler, model 1069 Stryker Medical 3800 E. Centre Ave…The fowler of the bed is raised by a crank. The crank cosnsists of a steel screw that moves through a brass… | Stryker Medical Div. of Stryker Corporation | 02/26/2010Terminated |
| Z-2170-2010 | Hill-Rom Basic Care Bed, P1441A (Non-electric), Hill Rom Batesville, IN. Intended for…The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the… | Hill-Rom, Inc. | 09/16/2009Terminated |
| Z-2167-2010 | Hill-Rom 305 Bed, P1441B - Non electric, Hill Rom Batesville, IN. Intended for low to…The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the… | Hill-Rom, Inc. | 09/16/2009Terminated |