FNLClass II
Bed, Ac-Powered Adjustable Hospital
21 CFR 880.5100 / General Hospital
FNL is the FDA product code for Bed, Ac-Powered Adjustable Hospital, a class II device type, regulated under 21 CFR 880.5100. As of , FDA records hold 70 510(k) clearances under this code, the most recent dated , and 155 recalls.
Classification record
- Product code
- FNL
- Device name
- Bed, Ac-Powered Adjustable Hospital
- Regulation
- 21 CFR 880.5100
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 70
- Ingested recalls
- 155
Clearances, product code FNL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 2 |
| 1985 | 4 |
| 1986 | 5 |
| 1987 | 4 |
| 1988 | 8 |
| 1989 | 5 |
| 1990 | 3 |
| 1991 | 1 |
| 1992 | 2 |
| 1993 | 8 |
| 1994 | 2 |
| 1995 | 6 |
| 1996 | 4 |
| 1997 | 8 |
| 1998 | 2 |
| 2010 | 1 |
| 2021 | 1 |
Applicants with the most clearances
Product code FNL| Applicant | Clearances |
|---|---|
| Med Service, Inc. | 6 |
| Hill-Rom Inc. | 5 |
| Stryker Corp. | 5 |
| Carrom Healthcare, Inc. | 4 |
| KCI USA, Inc. | 3 |
| Surgi-Med, Inc. | 3 |
| Vail Products, Inc. | 3 |
| Batesville American Mfg. Co. | 2 |
| Equi-Tron Mfg., Inc. | 2 |
| G.W. Healthcare, Inc. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this code- 5 Minds Mobility
- Accora Ltd
- Advanced Instrumentations, Inc.
- Agiliti Health - Ellis
- Agiliti Health - Hays
- Agiliti Health - Milwaukee
- Alpine HC Limited T/a Opera Beds
- Amico Beds Corporation
- Anhui Longway Medical Technology Co., Ltd
- Apex Health Care Mfg., Inc.
- ArjoHuntleigh Polska Sp. zo.o.
- Athena Healthcare Products
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
