I-Motion

Stimulator, Muscle, Powered, For Muscle Conditioning

I-Motion Group Global Iberica S.L.

The following data is part of a premarket notification filed by I-motion Group Global Iberica S.l. with the FDA for I-motion.

Pre-market Notification Details

• Device ID: K212413
• 510k Number: K212413
• Device Name: I-Motion
• Classification: Stimulator, Muscle, Powered, For Muscle Conditioning
• Applicant: I-Motion Group Global Iberica S.L. Calle Loeches 66.8 CP Alcorcon, ES 28925
• Contact: Jose Luis Soto Belloso
• Correspondent: Jose Luis Soto Belloso; I-Motion Group Global Iberica S.L. Calle Loeches 66.8 CP Alcorcon, ES 28925
• Product Code: NGX
• CFR Regulation Number: 890.5850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-08-03
• Decision Date: 2022-05-26