Vera

System, Optical Position/movement Recording

Reflexion Health, Inc.

The following data is part of a premarket notification filed by Reflexion Health, Inc. with the FDA for Vera.

Pre-market Notification Details

• Device ID: K182333
• 510k Number: K182333
• Device Name: Vera
• Classification: System, Optical Position/movement Recording
• Applicant: Reflexion Health, Inc. 225 Broadway Ste. 300 San Diego, CA 92101
• Contact: Walter Cordiglia
• Correspondent: Walter Cordiglia; Reflexion Health, Inc. 225 Broadway Ste. 300 San Diego, CA 92101
• Product Code: LXJ
• CFR Regulation Number: 890.5360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-08-28
• Decision Date: 2019-04-09