HELIO

Wheelchair, Mechanical

MOTION COMPOSITES

The following data is part of a premarket notification filed by Motion Composites with the FDA for Helio.

Pre-market Notification Details

• Device ID: K120628
• 510k Number: K120628
• Device Name: HELIO
• Classification: Wheelchair, Mechanical
• Applicant: MOTION COMPOSITES 519 J-OSWALD-FOREST SUITE 101 Saint-roch-de-l' Achigan, CA J063h0
• Contact: Vincent Lecuyer
• Correspondent: Vincent Lecuyer; MOTION COMPOSITES 519 J-OSWALD-FOREST SUITE 101 Saint-roch-de-l' Achigan, CA J063h0
• Product Code: IOR
• CFR Regulation Number: 890.3850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-01
• Decision Date: 2012-12-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00811774000031	K120628	000
00811774000024	K120628	000