Cleared Traditional

Next Generation iBOT

K172601 · Deka Research & Development Corp. · Physical Medicine
Mar 2018
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K172601 is an FDA 510(k) clearance for the Next Generation iBOT, 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 review panel. Regulated under 21 CFR 890.3890.

Submission Details

510(k) Number K172601 FDA.gov
FDA Decision Cleared 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

Device Classification

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.