FNL · Bed, Ac-Powered Adjustable Hospital
General Hospital · 21 CFR 880.5100 · Class 2
Overview
| Product Code | FNL |
|---|---|
| Device Name | Bed, Ac-Powered Adjustable Hospital |
| Regulation | 21 CFR 880.5100 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (20 of 70)
Showing 20 most recent of 70 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K202964 | iBed Wireless with iBed Mobile | Stryker Corporation | Jun 18, 2021 | SESE |
| K103536 | IBED WIRELESS WITH IBED AWARENESS | Stryker Corporation | Dec 16, 2010 | SESE |
| K982783 | VAIL 1000 ENCLOSED BED | Vail Products, Inc. | Oct 5, 1998 | SESE |
| K974296 | MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED | Invacare Corp. | Jan 6, 1998 | SESE |
| K974254 | BENEFIT B3--- SERIES | M.C. Healthcare Products, Inc. | Dec 16, 1997 | SESE |
| K972115 | VOLKER HOSPITAL BED, MODEL K960 | Volker Healthcare, Inc. | Aug 29, 1997 | SESE |
| K971546 | SOMA 900 TRANSPORT BED | Nova Technologies, Inc. | Jul 10, 1997 | SESE |
| K963622 | VAIL 2000 ENCLOSED BED | Vail Products, Inc. | May 7, 1997 | SESE |
| K963589 | VAIL 3000 BED ENCLOSURE | Vail Products, Inc. | Apr 21, 1997 | SESE |
| K962942 | TOTALCARE | Hill-Rom, Inc. | Feb 3, 1997 | SESE |
| K963701 | SOMA SAFE ENCLOSURE | Nova Technology Corp. | Jan 24, 1997 | SESE |
| K964246 | NOVABED PATIENT TRANSFER SYSTEM | Nova Technology Corp. | Jan 22, 1997 | SESE |
| K964515 | ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 | M.C. Healthcare Products, Inc. | Dec 31, 1996 | SESE |
| K962250 | CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED | Carroll Healthcare, Inc. | Oct 21, 1996 | SESE |
| K962763 | 2000 MODULAR THIRTY-NINE | Equi-Tron Mfg., Inc. | Oct 7, 1996 | SESE |
| K951514 | SSC MODEL 4000 SERIES | Ssc Medical Products, Inc. | Mar 6, 1996 | SESE |
| K951735 | JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL | Joerns Healthcare, Inc. | Aug 18, 1995 | SESE |
| K951161 | MC ACCLAIM Q6000 BED | Janco Consulting Services | May 9, 1995 | SESE |
| K945042 | ELITE 3 LOW AIR LOSS BED | Pegabus Egerton, Ltd. | Mar 16, 1995 | SESE |
| K946208 | VOLKER NURSING BED MODEL 2080E & 2090E | Volker Healthcare, Inc. | Mar 14, 1995 | SESE |
Top Applicants
- Med Service, Inc. — 6 clearances
- Hill-Rom, Inc. — 5 clearances
- Carrom Healthcare, Inc. — 4 clearances
- Kinetic Concepts, Inc. — 3 clearances
- Stryker Corp. — 3 clearances
