510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233362Substantially Equivalent

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)

Pelvital USA, Inc., Eagan MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233362 is the FDA 510(k) clearance record for Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0), a class II device, cleared for Pelvital USA, Inc. on under FDA product code HIR (Perineometer). FDA records list 5 510(k) clearances for Pelvital USA, Inc., from to . As of , FDA records show no recalls naming K233362.

Clearance record

Decision date
Received
(88 days to decision)
Product code
HIR Perineometer
Regulation
21 CFR 884.1425
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Pelvital USA, Inc. 860 Blue Gentian Rd., Suite 200, Eagan MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIR

Trailing 12 months
1 clearance under product code HIR in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260