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510(k) K252334

PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) by Pontemedag — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2026
Date Received
July 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Device Class
Class II
Regulation Number
876.5320
Review Panel
GU
Submission Type

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