IKZClass II
Bed, Patient Rotation, Powered
21 CFR 890.5225 / Physical Medicine
IKZ is the FDA product code for Bed, Patient Rotation, Powered, a class II device type, regulated under 21 CFR 890.5225. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and 12 recalls.
Classification record
- Product code
- IKZ
- Device name
- Bed, Patient Rotation, Powered
- Regulation
- 21 CFR 890.5225
- Device class
- Class II
- Review panel
- Physical Medicine
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 17
- Ingested recalls
- 12
Clearances, product code IKZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1982 | 2 |
| 1984 | 2 |
| 1987 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 2 |
Applicants with the most clearances
Product code IKZ| Applicant | Clearances |
|---|---|
| KCI USA, Inc. | 3 |
| Hill-Rom Inc. | 2 |
| Ethos Medical Products, Ltd. | 1 |
| Gaymar Industries, Inc. | 1 |
| Invacare GmbH | 1 |
| J. H. Emerson Co. | 1 |
| Med-Ez, Inc. | 1 |
| Motion Manufacturers, Inc. | 1 |
| Probed Medical Technologies, Inc. | 1 |
| Progressive Medical Technology, 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.