FNJ · Bed, Manual
General Hospital · 21 CFR 880.5120 · Class 1
Overview
| Product Code | FNJ |
|---|---|
| Device Name | Bed, Manual |
| Regulation | 21 CFR 880.5120 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A manual adjustable hospital bed is a device intended for medical purposes that consists of a bed with a manual mechanism operated by an attendant to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 39)
Showing 20 most recent of 39 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K934298 | KING KRIB | Noritage, Inc. | Jan 26, 1994 | SESE |
| K892877 | CRADLE, HOSPITAL BED CLOTHING | Warsaw Orthopedic, Inc. | Jun 15, 1989 | SESE |
| K885241 | BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT | King Mfg. Co. | Feb 24, 1989 | SESE |
| K884542 | SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED | Commercial Products & Engineering Co. | Nov 21, 1988 | SESE |
| K881725 | ENVIROTENT (BED) | Envirotents, Inc. | Nov 8, 1988 | SESE |
| K881961 | MSI STANDARD BED MODELS: L1097-64 AND L1085-64 | Med Service, Inc. | Nov 1, 1988 | SESE |
| K881964 | MSI 3003 SERIES BED | Med Service, Inc. | Jun 28, 1988 | SESE |
| K881962 | MSI 2005 SERIES BED | Med Service, Inc. | Jun 3, 1988 | SESE |
| K881043 | FOLDING HOSPITAL COT NSN 6530-00-299-8517 | Junkin Safety Appliance Co., Inc. | Apr 12, 1988 | SESE |
| K870166 | PLATFORM MATTRESS W/DISPOSABLE BEDPAN BAG | George C. Kuhn | Mar 13, 1987 | SESE |
| K870310 | VSID MEDICAL THREE-FOLDING BED | China National Medicines & Health Prod. I/E Corp. | Feb 10, 1987 | SESE |
| K864667 | PENOX HOSPITAL BED | Penox Technologies, Inc. | Jan 21, 1987 | SESE |
| K863694 | BED/ADJUST/HOSPITAL/FOLDING FIELD WITHOUT MATTRESS | Brenner Metal Prod Corp. | Jan 20, 1987 | SESE |
| K863691 | COT, FOLDING, HOSPITAL, ALUMINUM | Brenner Metal Prod Corp. | Jan 20, 1987 | SESE |
| K863688 | ROD, IRRIGATOR, SUPPORTING TELESCOPING, TYPE | Brenner Metal Prod Corp. | Jan 20, 1987 | SESE |
| K863685 | CART, ORTHOPEDIC BED, STRYKER | Brenner Metal Prod Corp. | Jan 15, 1987 | SESE |
| K864878 | ICU/CPU TRANSPORT TRAY | Orthopedic Systems, Inc. | Jan 6, 1987 | SESE |
| K864203 | NESBIT EVANS NURSING HOME BED | J. Nesbit Evans & Co. | Nov 7, 1986 | SESE |
| K863748 | HOSPITAL BED | Global Medical Prods, Inc. | Oct 9, 1986 | SESE |
| K861678 | COT, FOLDING HOSPITAL ALUMINUM - MANUAL BED | Sierra Corp. | May 8, 1986 | SESE |
Top Applicants
- Brenner Metal Prod Corp. — 4 clearances
- Med Fusion Systems, Inc. — 3 clearances
- Med Service, Inc. — 3 clearances
- Ali-Oop Co., Inc. — 1 clearance
- Alimed, Inc. — 1 clearance
