OculoMotor Technologies

Primary DI
00860012940608
Brand
OculoMotor Technologies
Company
Oculomotor Technologies Inc.
Model
VERVE
Device description
Virtual Eye Rotation Vision Exercises for Convergence Insufficiency Therapy
Published
2025-01-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SBNDigital Therapy Device For Convergence Insufficiency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBNDigital Therapy Device For Convergence InsufficiencyOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232930000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232930000VERVEOculomotor Technologies2024-06-13SBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012940608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012940608008600129406088600129406080860012940608

GMDN Terms#

Term, Definition table
TermDefinition
Virtual-display routine exercise softwareA software package intended to be used on a non-medical computerized device and a display unit (e.g., television) to provide virtual exercise-based interactive activities/games for daily/regular use to help maintain or improve physical/mental health. It may be intended for use with one or more type(s) of electronic exercise device(s) [e.g., cycle device] and may provide one or more type(s) of on-screen interaction (e.g., video of a journey). It is not intended to provide specific biomechanical function analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081121764
Device count
1
Lot or batch
true
Serial number
true