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510(k) K210920

Device
IBOT Personal Mobility Device (iBOT PMD)
Applicant
Mobius Mobility
510(k) number
K210920
Product code
IMK  
Decision
Substantially Equivalent (SESE)
Decision date
2021-06-16
Date received
2021-03-29
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
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), Device, Applicant table
510(k)DeviceApplicantDecision date
K243442iBOT® PMDMobius Mobility2025-01-30
K172601Next Generation iBOTDeka Research & Development Corp.2018-03-02

Legacy Summary#

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FDA Review#

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