← FDA Medical Device Classifications

Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy

OXW · Not classified · Unknown

Classification

FDA Product Code
OXW
Device class
Not classified
Regulation
Review panel
OP
Medical specialty
Unknown
Submission type
3
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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