K172601 is an FDA 510(k) clearance for the Next Generation iBOT. This device is classified as a Wheelchair, Stair Climbing (Class II - Special Controls, product code IMK).
Submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on March 2, 2018, 184 days after receiving the submission on August 30, 2017.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3890. 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..
| 510(k) Number | K172601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2017 |
| Decision Date | March 02, 2018 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMK - Wheelchair, Stair Climbing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3890 |
| 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. |