ILK
- Product code
- ILK
- Device name
- Transport, Patient, Powered
- Device class
- Class 2
- 21 CFR
- 21 CFR 890.5150
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 36 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240843 | 2024-10-07 | Climbing Steps, Inc. | GENESIS (MS-P02-GEN) | — |
Official FDA classification page: ILK
Classification and pathway per current FDA publications. Data from openFDA (CC0).