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: K150462
• 510k Number: K150462
• Device Name: Vera
• Classification: System, Optical Position/movement Recording
• Applicant: Reflexion Health, Inc. 223 Broadway, Suite 650 San Diego, CA 92130
• Contact: Huan Tran
• Correspondent: Huan Tran; Reflexion Health, Inc. 223 Broadway, Suite 650 San Diego, CA 92130
• Product Code: LXJ
• CFR Regulation Number: 890.5360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-02-23
• Decision Date: 2015-10-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860001498400	K150462	000