510(k) K171896

Feminine Personal Trainer (FPT) by Ralston Group — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2017
Date Received
June 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perineometer
Device Class
Class II
Regulation Number
884.1425
Review Panel
GU
Submission Type