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: K192474
• 510k Number: K192474
• Device Name: VERA
• Classification: System, Optical Position/movement Recording
• Applicant: Reflexion Health, Inc. 225 Broadway Ste. 300 San Diego, CA 62101
• Contact: Walter Cordiglia
• Correspondent: Walter Cordiglia; Reflexion Health, Inc. 225 Broadway Ste. 300 San Diego, CA 62101
• Product Code: LXJ
• CFR Regulation Number: 890.5360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-09-10
• Decision Date: 2019-10-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556803868	K192474	000