Next Generation iBOT

FDA 510(k) K172601 · Deka Research & Development Corp.

Substantially Equivalent

510(k) numberK172601

Submission

Device name
Next Generation iBOT
Applicant
Deka Research & Development Corp.
Manchester, NH, US
Received
August 30, 2017
Decision date
March 2, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IMK – Wheelchair, Stair Climbing
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3890
Specialty
Physical Medicine

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.

Other 510(k)s with product code IMK

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K243442iBOT® PMDIMK · Traditional Mobius Mobility01/30/2025SE
K210920iBOT Personal Mobility Device (iBOT PMD)IMK · Traditional Mobius Mobility06/16/2021SE

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Questions and answers

When was Next Generation iBOT cleared by the FDA?

Next Generation iBOT (K172601) received a 510(k) decision of Substantially Equivalent on March 2, 2018, 184 days after the submission was received.

What is the product code of K172601?

The FDA product code is IMK – Wheelchair, Stair Climbing, a Class II (moderate risk) device regulated under 21 CFR 890.3890.