Product code SBN

Device name
Digital Therapy Device For Convergence Insufficiency
Medical specialty
Ophthalmic
Device class
1
Regulation number
886.1290
Review panel
OP
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency
Source
FDA openFDA device classification dataset