IMK — Wheelchair, Stair Climbing Class II
FDA product code IMK covers "Wheelchair, Stair Climbing", a Class II medical device regulated under 21 CFR 890.3890. Submissions are reviewed by the Physical Medicine panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IMK
- Device Class
- Class II
- Regulation Number
- 890.3890
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Definition
A device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility.