510(k) K172601
K172601 is an FDA 510(k) premarket notification submitted by Deka Research & Development Corp. for the device "Next Generation iBOT". The FDA issued a decision of Substantially Equivalent on March 2, 2018. The device falls under product code IMK (Wheelchair, Stair Climbing), a Class II device regulated under 21 CFR 890.3890. Deka Research & Development Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 2018
- Date Received
- August 30, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wheelchair, Stair Climbing
- Device Class
- Class II
- Regulation Number
- 890.3890
- Review Panel
- PM
- Submission Type
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.