Last synced on 30 May 2025 at 11:05 pm

Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy

Page Type
Product Code
Definition
Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through the electrodes to the patient's eyelid to create a microcurrent loop that flows through the retina.
Physical State
Electrical stimulation unit with leads and cutaneous electrodes
Technical Method
Applies an electrical current through electrodes on a patient's eyelid (skin)
Target Area
Eyelid
Review Panel
Ophthalmic
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OXW is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy

Page Type
Product Code
Definition
Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through the electrodes to the patient's eyelid to create a microcurrent loop that flows through the retina.
Physical State
Electrical stimulation unit with leads and cutaneous electrodes
Technical Method
Applies an electrical current through electrodes on a patient's eyelid (skin)
Target Area
Eyelid
Review Panel
Ophthalmic
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OXW is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.