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510(k) K252809

in2 Smart (in2S) by Virility Medical , Ltd. — Product Code QRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2026
Date Received
September 3, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
Device Class
Class II
Regulation Number
876.5026
Review Panel
GU
Submission Type

A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.

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