FDA.report

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

Related Records

Applicant Contact

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

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code IMK

510(k)DeviceApplicantDecision date
K210920iBOT Personal Mobility Device (iBOT PMD)Mobius Mobility2021-06-16
K172601Next Generation iBOTDeka Research & Development Corp.2018-03-02