510(k) K243442

Device: iBOT® PMD
Applicant: Mobius Mobility
510(k) number: K243442
Product code: IMK
Decision: Substantially Equivalent (SESE)
Decision date: 2025-01-30
Date received: 2024-11-06
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: N

Applicant Contact#

Contact: Joseph Sullivan
Address: 540 Commercial St. Suite 310 Manchester NH US 03101 03101

FDA Registration Numbers#

1220973
3014522447

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IMK#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K210920	iBOT Personal Mobility Device (iBOT PMD)	Mobius Mobility	2021-06-16
K172601	Next Generation iBOT	Deka Research & Development Corp.	2018-03-02