VERA

GUDID 00860001498400

REFLEXION HEALTH, INC.

Virtual-display rehabilitation system, non-supportive, clinical

• Primary Device ID: 00860001498400
• NIH Device Record Key: 98b18c79-9809-4cc6-982e-6ba7ea47ba5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERA
• Version Model Number: 3.3.2-2.13.0
• Company DUNS: 078764018
• Company Name: REFLEXION HEALTH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001498400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150462

FDA Product Code

• LXJ: System, Optical Position/Movement Recording

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-08
• Device Publish Date: 2019-06-30