I-Motion— 510(k) K212413

Substantially Equivalent

I-Motion Group Global Iberica S.L.

FDA 510(k) clearance K212413 for I-Motion, Substantially Equivalent on 2022-05-26. Applicant: I-Motion Group Global Iberica S.L.. Device class: 2.

Clearance details

Applicant
I-Motion Group Global Iberica S.L.
Product code
Code NGX
Device class
Class 2
Regulation
21 CFR 890.5850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Alcorcon, ES
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