510(k) K172601

Device: Next Generation IBOT
Applicant: DEKA Research & Development Corp
510(k) number: K172601
Product code: IMK
Decision: Substantially Equivalent (SESE)
Decision date: 2018-03-02
Date received: 2017-08-30
Regulation: 890.3890
Classification name: Wheelchair, Stair Climbing
Medical specialty: Physical Medicine
Review panel: Physical Medicine
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Roger Leroux
Address: 340 Commercial St. Manchester NH US 03101 03101

FDA Registration Numbers#

1220973
3014522447

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00857584008003	iBOT	MOBIUS MOBILITY LLC	2020-01-08

Other 510(k) Records For Product Code IMK #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K243442	iBOT® PMD	Mobius Mobility	2025-01-30
K210920	iBOT Personal Mobility Device (iBOT PMD)	Mobius Mobility	2021-06-16

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases