FDA product code ILK: Transport, Patient, Powered
ILK is the FDA product code for transport, patient, powered. It is a Class II device, regulated under 21 CFR 890.5150 and reviewed by the Physical Medicine panel. FDA has cleared 36 510(k) submissions under ILK, 2 in the last five years, from 25 different applicants. The average 510(k) review took 78 days (median 58); 194 days on average over the last three years. FDA has posted 7 recalls for ILK devices.
Definition
A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.
Classification
| Field | Value |
|---|---|
| Device name | Transport, Patient, Powered |
| Device class | Class II |
| Regulation | 21 CFR 890.5150 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for ILK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 127 |
| 2024 | 1 | 194 |
Top ILK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bruno Independent Living Aids, Inc. | 7 | 2012-02-01 |
| Services Industriels Savaria, Inc. | 3 | 2003-03-04 |
| Aat Alber Antriebstechnik GmbH | 2 | 2014-02-06 |
| Thyssenkrupp Accessibility B.V. | 2 | 2012-11-01 |
| T.B.S., Inc. | 2 | 1989-02-13 |
20 more applicants have ILK clearances. See the full list in Caduvo.
Most recent ILK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240843 | Climbing Steps, Inc. | GENESIS (MS-P02-GEN) | 2024-10-07 | 194 |
| K222818 | Stryker Medical | Xpedition Powered Stair Chair (625700000000) | 2023-01-24 | 127 |
| K130864 | Aat Alber Antriebstechnik GmbH | C-MAX+ (PLUS) | 2014-02-06 | 315 |
| K121560 | Thyssenkrupp Accessibility B.V. | LEVANT, HOMEGLIDE | 2012-11-01 | 156 |
| K121561 | Thyssenkrupp Accessibility B.V. | FLOW2, SWING | 2012-10-26 | 150 |
Recalls for ILK devices
7 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-04-12.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code ILK?
ILK is the FDA product code for transport, patient, powered. It is a Class II device, regulated under 21 CFR 890.5150 and reviewed by the Physical Medicine panel.
What device class is ILK?
Class II, regulation 21 CFR 890.5150. Typical premarket route: 510(k).
How long does a 510(k) take for product code ILK?
Across 36 cleared submissions the average was 78 days from receipt to decision (median 58).
Which companies have the most ILK clearances?
Bruno Independent Living Aids, Inc. (7); Services Industriels Savaria, Inc. (3); Aat Alber Antriebstechnik GmbH (2); Thyssenkrupp Accessibility B.V. (2); T.B.S., Inc. (2).
Have ILK devices been recalled?
Yes: 7 product recalls across 4 recall events; the most recent began 2017-04-12.
Next steps
- Run an FDA pathway report with predicate devices for product code ILK
- Run a recall and safety report across every ILK manufacturer
- Watch product code ILK 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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