Cleared Traditional

K172601 - Next Generation iBOT (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K172601 is an FDA 510(k) clearance for the Next Generation iBOT. Classified as Wheelchair, Stair Climbing (product code IMK), Class II - Special Controls.

Submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on March 2, 2018 after a review of 184 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3890 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Deka Research & Development Corp. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 115d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IMK Wheelchair, Stair Climbing
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.