FNLFDA Class 2 · 21 CFR 880.5100
Bed, Ac-Powered Adjustable Hospital
Device family · General Hospital
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
70
Manufacturers
7
Flagged signals
15
Adverse-event reports
77,678
Code matrix
| FDA product code | FNL |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5100 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| 2013 | 3 | 1190.9 | 2,471 | |
| Other | 2013 | 12 | 55.4 | 589 |
| Other | 2011 | 6 | 35.6 | 169 |
| Other | 2011 | 5 | 27.5 | 103 |
| Other | 2010 | 5 | 23.1 | 85 |
| Other | 2013 | 4 | 22.0 | 61 |
| Other | 2010 | 60 | 16.9 | 884 |
| Other | 2011 | 3 | 13.9 | 24 |
| Other | 2013 | 7 | 10.8 | 53 |
| Death | 2017 | 4 | 7.2 | 16 |
| Death | 2010 | 7 | 7.1 | 31 |
| Other | 2011 | 5 | 3.8 | 8 |
| Other | 2010 | 97 | 2.5 | 88 |
| Other | 2011 | 95 | 2.5 | 82 |
| Other | 2013 | 78 | 2.3 | 58 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 77,678 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| HILL-ROM, INC. | 5 | 1997 | — |
| Kinetic Concepts, Inc. | 3 | 1995 | — |
| Stryker Corp. | 3 | 1993 | — |
| Stryker Corporation | 2 | 2021 | 0.13 |
| Invacare Corp. | 2 | 1998 | — |
| Stryker Medical | 1 | 1995 | — |
| MEDLINE INDUSTRIES, INC. | 1 | 1993 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
iBed Wireless with iBed Mobile · Stryker Corporation510(k) · 2021-06-18
IBED WIRELESS WITH IBED AWARENESS · Stryker Corporation510(k) · 2010-12-16
VAIL 1000 ENCLOSED BED · Vail Products, Inc.510(k) · 1998-10-05
MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED · Invacare Corp.510(k) · 1998-01-06
BENEFIT B3--- SERIES · M.C. Healthcare Products, Inc.510(k) · 1997-12-16
VOLKER HOSPITAL BED, MODEL K960 · Volker Healthcare, Inc.510(k) · 1997-08-29
SOMA 900 TRANSPORT BED · Nova Technologies, Inc.510(k) · 1997-07-10
VAIL 2000 ENCLOSED BED · Vail Products, Inc.510(k) · 1997-05-07
VAIL 3000 BED ENCLOSURE · Vail Products, Inc.510(k) · 1997-04-21
TOTALCARE · Hill-Rom, Inc.510(k) · 1997-02-03
SOMA SAFE ENCLOSURE · Nova Technology Corp.510(k) · 1997-01-24
NOVABED PATIENT TRANSFER SYSTEM · Nova Technology Corp.510(k) · 1997-01-22
ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 · M.C. Healthcare Products, Inc.510(k) · 1996-12-31
CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED · Carroll Healthcare, Inc.510(k) · 1996-10-21
2000 MODULAR THIRTY-NINE · Equi-Tron Mfg., Inc.510(k) · 1996-10-07
SSC MODEL 4000 SERIES · Ssc Medical Products, Inc.510(k) · 1996-03-06
JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL · Joerns Healthcare, Inc.510(k) · 1995-08-18
MC ACCLAIM Q6000 BED · Janco Consulting Services510(k) · 1995-05-09
ELITE 3 LOW AIR LOSS BED · Pegabus Egerton, Ltd.510(k) · 1995-03-16
VOLKER NURSING BED MODEL 2080E & 2090E · Volker Healthcare, Inc.510(k) · 1995-03-14
STRYKER AGILITY INTENSIVE CARE BED · Stryker Medical510(k) · 1995-03-14
BARIKARE PLUS · Kinetic Concepts, Inc.510(k) · 1995-02-16
AIRHYTHM HEALTHCARE BED · Healthcare Designs510(k) · 1994-06-21
S.S.C. MEDICAL MODEL 5000 SERIES BED · Super Sagless Corp.510(k) · 1994-02-09
MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES · Medline Industries, Inc.510(k) · 1993-11-30
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.