Product code FNL
- Device name
- Bed, Ac-Powered Adjustable Hospital
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5100
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202964 | iBed Wireless with iBed Mobile | Stryker Corporation | 2021-06-18 |
| K103536 | IBED WIRELESS WITH IBED AWARENESS | Stryker Corporation | 2010-12-16 |
| K982783 | VAIL 1000 ENCLOSED BED | Vail Products, Inc. | 1998-10-05 |
| K974296 | MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED | Invacare Corp. | 1998-01-06 |
| K974254 | BENEFIT B3--- SERIES | M.C. Healthcare Products, Inc. | 1997-12-16 |
| K972115 | VOLKER HOSPITAL BED, MODEL K960 | Volker Healthcare, Inc. | 1997-08-29 |
| K971546 | SOMA 900 TRANSPORT BED | Nova Technologies, Inc. | 1997-07-10 |
| K963622 | VAIL 2000 ENCLOSED BED | Vail Products, Inc. | 1997-05-07 |
| K963589 | VAIL 3000 BED ENCLOSURE | Vail Products, Inc. | 1997-04-21 |
| K962942 | TOTALCARE | Hill-Rom, Inc. | 1997-02-03 |
| K963701 | SOMA SAFE ENCLOSURE | Nova Technology Corp. | 1997-01-24 |
| K964246 | NOVABED PATIENT TRANSFER SYSTEM | Nova Technology Corp. | 1997-01-22 |
| K964515 | ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 | M.C. Healthcare Products, Inc. | 1996-12-31 |
| K962250 | CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED | Carroll Healthcare, Inc. | 1996-10-21 |
| K962763 | 2000 MODULAR THIRTY-NINE | Equi-Tron Mfg., Inc. | 1996-10-07 |
| K951514 | SSC MODEL 4000 SERIES | Ssc Medical Products, Inc. | 1996-03-06 |
| K951735 | JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL | Joerns Healthcare, Inc. | 1995-08-18 |
| K951161 | MC ACCLAIM Q6000 BED | Janco Consulting Services | 1995-05-09 |
| K945042 | ELITE 3 LOW AIR LOSS BED | Pegabus Egerton, Ltd. | 1995-03-16 |
| K946149 | STRYKER AGILITY INTENSIVE CARE BED | Stryker Medical | 1995-03-14 |
| K946208 | VOLKER NURSING BED MODEL 2080E & 2090E | Volker Healthcare, Inc. | 1995-03-14 |
| K945664 | BARIKARE PLUS | Kinetic Concepts, Inc. | 1995-02-16 |
| K935837 | AIRHYTHM HEALTHCARE BED | Healthcare Designs | 1994-06-21 |
| K934090 | S.S.C. MEDICAL MODEL 5000 SERIES BED | Super Sagless Corp. | 1994-02-09 |
| K932663 | MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES | Medline Industries, Inc. | 1993-11-30 |
| K930703 | ADJUSTABLE BED | Maxwell Products, Inc. | 1993-11-22 |
| K931581 | GLENN BED | Kinetic Concepts, Inc. | 1993-10-21 |
| K931482 | STRYKER MPS ACUTE CARE BED | Stryker Corp. | 1993-09-09 |
| K926435 | COMFORTADE | Sensible Products | 1993-08-19 |
| K930234 | FLH1768M SERIES HOSPITAL BED | Bertec Medical, Inc. | 1993-07-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04719876191663 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876191625 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876191595 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876191588 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876190932 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876190598 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876190581 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876190574 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876190055 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876190277 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 00840117324527 | Bariatric HD Long-Term Care Bed, DB600, 5 Function Low Bed, Expands to 54" | Dynarex Corporation | 2022-11-21 |
| 00840117303140 | Composite Boards Adapter | Dynarex Corporation | 2021-02-08 |
| 00840117303867 | Clip-On Staff Control Adapter | Dynarex Corporation | 2021-02-08 |
| 00840117303157 | Composite Boards Adapter | Dynarex Corporation | 2021-02-08 |
| 00840117303133 | Composite Headboard and Footboard | Dynarex Corporation | 2021-02-08 |
| 00840117302914 | Long-Term Care Bed D300, 5 Function Low Bed | Dynarex Corporation | 2021-02-03 |
| 00840117302907 | Long Term Care Bed, D200 | Dynarex Corporation | 2021-02-03 |
| 00840117302891 | Long-Term Care Bed, D100 | Dynarex Corporation | 2021-02-03 |
| 00840117302945 | Bariatric HD Long-Term Care Bed, DB300, 5 Function Low Bed | Dynarex Corporation | 2021-02-03 |
| 00616784040820 | Homecare Hi Low Bed | Dynarex Corporation | 2021-02-02 |
| 00616784040813 | Homecare Hi Low Bed | Dynarex Corporation | 2021-02-02 |
| 00616784040530 | Bariatric HD Home Care Full Electric Bed Foot Deck 48" | Dynarex Corporation | 2021-02-02 |
| 00616784040523 | Bariatric HD Home Care Full Electric Bed, Head Deck, 48" | Dynarex Corporation | 2021-02-02 |
| 00616784040431 | Home Care Bed | Dynarex Corporation | 2021-02-02 |
| 00616784040424 | Bariatric Full Electric Home Care Bed Head Deck 42" | Dynarex Corporation | 2021-02-02 |
| 00616784040714 | Transport Bar - Homecare | Dynarex Corporation | 2019-11-04 |
| 00616784040516 | Bariatric HD Home Care Full Electric Bed,Head Board/Foot Board, 48" | Dynarex Corporation | 2018-05-23 |
| 00616784040417 | Bariatric Full Electric Home Care Bed, Head Board/Foot Board, 42" | Dynarex Corporation | 2018-05-23 |
| 00616784040110 | Ridgewood Collection Home Care Bed, Semi-Electric | Dynarex Corporation | 2018-05-23 |
| 00616784046716 | Long Term Care Swing Rail, Off White | Dynarex Corporation | 2018-05-19 |