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Vera

FDA UDI

Class II (US FDA UDI)

by Reflexion Health, Inc.

Identity

Trade Name
VERA FDA UDI
Generic Name
Virtual-display rehabilitation system, non-supportive, clinical FDA UDI
Model / Reference
3.3.2-2.13.0 FDA UDI

Identifiers

Primary DI / UDI-DI
00860001498400 FDA UDI
510(k) Number
K150462 FDA UDI
FDA Product Code
LXJ FDA UDI
GMDN Term
Virtual-display rehabilitation system, non-supportive, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5360 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Virtual-display rehabilitation system, non-supportive, clinical

Vera by Reflexion Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Virtual-display rehabilitation system, non-supportive, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Reflexion Health, Inc.

Sources (1)

  • FDA UDI 98b18c79-9809-4cc6-982e-6ba7ea47ba5e 33 fields · synced May 31, 2026