FNJClass I
Bed, Manual
21 CFR 880.5120 / General Hospital
FNJ is the FDA product code for Bed, Manual, a class I device type, regulated under 21 CFR 880.5120. As of , FDA records hold 39 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- FNJ
- Device name
- Bed, Manual
- Regulation
- 21 CFR 880.5120
- Device class
- Class I
- Review panel
- General Hospital
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 39
- Ingested recalls
- 7
Clearances, product code FNJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1978 | 3 |
| 1979 | 3 |
| 1980 | 1 |
| 1981 | 2 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 1 |
| 1985 | 4 |
| 1986 | 4 |
| 1987 | 8 |
| 1988 | 6 |
| 1989 | 2 |
| 1994 | 1 |
Applicants with the most clearances
Product code FNJ| Applicant | Clearances |
|---|---|
| Brenner Metal Prod Corp. | 4 |
| Med Fusion Systems, Inc. | 3 |
| Med Service, Inc. | 3 |
| Ali-Oop Co., Inc. | 1 |
| Alimed, LLC | 1 |
| Am Fab, Inc. | 1 |
| Carrom Healthcare, Inc. | 1 |
| China National Medicines & Health Prod. I/E Corp. | 1 |
| Commercial Products & Engineering Co. | 1 |
| Danek Medical, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.