510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964577Substantially Equivalent

Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal Electrode(199205)

Empi, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964577 is the FDA 510(k) clearance record for INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205), a class II device, cleared for Empi on under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence). FDA records list 12 510(k) clearances for Empi, from to . As of , FDA records show no recalls naming K964577.

Clearance record

Decision date
Received
(71 days to decision)
Product code
KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Regulation
21 CFR 876.5320
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Empi 599 Cardigan Rd., St. Paul MN
510(k) summary
Summary
Third party review
No

Clearances, product code KPI

Trailing 12 months
7 clearances under product code KPI in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20262
May 20262
June 20261
July 20260
August 20260
September 20261
October 20260