Data / Medical devices / Spain / I-Motion Group Global Iberica SL.
I-Motion Group Global Iberica SL.: FDA-registered device maker in Madrid Madrid(Autonomous Community), Spain, 1 510(k) clearance
I-Motion Group Global Iberica SL. is registered with the FDA (registration 3023205383) in Madrid Madrid(Autonomous Community), Spain. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 26, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3023205383
- Address
- Calle Labradores 13, Boadilla del Monte, Madrid Madrid(Autonomous Community), Spain, 28660
- Owner or operator
- I-MOTION GROUP GLOBAL IBERICA SL. (10085323)
- Roles
- Manufacturer
- First device listed
- June 3, 2022
- Registered through
- 2026
- Brand names listed
- I-HomeFit, I-MOTION, I-Model, I-Shape Esthetic, I-Shape Sport, SQAI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 26, 2022 | K212413 | I-Motion | NGX | Substantially Equivalent | I-Motion Group Global Iberica S.L. | accessdata.fda.gov |
Compare with other makers
Updated May 26, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.