FDA product code INK: Stretcher, Wheeled, Powered
INK is the FDA product code for stretcher, wheeled, powered. It is a Class II device, regulated under 21 CFR 890.3690 and reviewed by the Physical Medicine panel. FDA has cleared 12 510(k) submissions under INK, from 12 different applicants. The average 510(k) review took 82 days (median 69). FDA has posted 16 recalls for INK devices.
Classification
| Field | Value |
|---|---|
| Device name | Stretcher, Wheeled, Powered |
| Device class | Class II |
| Regulation | 21 CFR 890.3690 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every INK clearance
Top INK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Winco Manufacturing, LLC | 1 | 2016-04-11 |
| Stryker Corporation | 1 | 2014-05-20 |
| Hill-Rom Co. | 1 | 2011-09-19 |
| Winco Mfg., LLC | 1 | 2011-04-22 |
| D.T. Davis Enterprises Ltd. T/A Hovertech Int'L | 1 | 2010-11-18 |
7 more applicants have INK clearances. See the full list in Caduvo.
Most recent INK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K152056 | Winco Manufacturing, LLC | Winco Model S550 Stretchair | 2016-04-11 | 262 |
| K140095 | Stryker Corporation | PRIME ZOOM STRETCHER | 2014-05-20 | 126 |
| K112502 | Hill-Rom Co. | PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 | 2011-09-19 | 20 |
| K110671 | Winco Mfg., LLC | WINCO STRETCHAIR | 2011-04-22 | 44 |
| K102236 | D.T. Davis Enterprises Ltd. T/A Hovertech Int'L | HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P | 2010-11-18 | 101 |
Recalls for INK devices
16 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-04-07.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code INK?
INK is the FDA product code for stretcher, wheeled, powered. It is a Class II device, regulated under 21 CFR 890.3690 and reviewed by the Physical Medicine panel.
What device class is INK?
Class II, regulation 21 CFR 890.3690. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code INK?
Across 12 cleared submissions the average was 82 days from receipt to decision (median 69).
Which companies have the most INK clearances?
Winco Manufacturing, LLC (1); Stryker Corporation (1); Hill-Rom Co. (1); Winco Mfg., LLC (1); D.T. Davis Enterprises Ltd. T/A Hovertech Int'L (1).
Have INK devices been recalled?
Yes: 16 product recalls across 6 recall events; the most recent began 2020-04-07.
Next steps
- Run an FDA pathway report with predicate devices for product code INK
- Run a recall and safety report across every INK manufacturer
- Watch product code INK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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