INKClass II
Stretcher, Wheeled, Powered
21 CFR 890.3690 / Physical Medicine
INK is the FDA product code for Stretcher, Wheeled, Powered, a class II device type, regulated under 21 CFR 890.3690. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 16 recalls.
Classification record
- Product code
- INK
- Device name
- Stretcher, Wheeled, Powered
- Regulation
- 21 CFR 890.3690
- 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
- Yes
- Ingested clearances
- 12
- Ingested recalls
- 16
Clearances, product code INK
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1985 | 1 |
| 1991 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2014 | 1 |
| 2016 | 1 |
Applicants with the most clearances
Product code INK| Applicant | Clearances |
|---|---|
| Stryker Corp. | 2 |
| Champion Mfg, Inc. | 2 |
| D.T. Davis Enterprises Ltd. T/A Hovertech Int'L | 1 |
| Hamilton Industries, Inc. | 1 |
| Hill-Rom Inc. | 1 |
| Isotechnologies, Inc. | 1 |
| STERIS Corporation | 1 |
| Savion Industries, Ltd. | 1 |
| Tri W-G, Inc. | 1 |
| Winco Manufacturing, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- 21ST Century Scientific, Inc.
- Anetic Aid Ltd
- Carevel Medical Systems Private Limited
- Champion Mfg, Inc.
- Dragon Medical Co.,Ltd
- FU Shun Hsing Technology Co., Ltd.
- Globus Medical, Inc.
- Hill-Rom de Mexico S de RL de CV
- Hill-Rom Inc.
- Jac Custom Pouches
- Jiangsu Yongxin Medical Equipment Co., Ltd
- Jiangyin Everise Medical Equipment Co., Ltd.
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.