510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K022433Substantially Equivalent

Neogenesys 2K

Sanexas Intl. GmbH, Lee'S Summit MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022433 is the FDA 510(k) clearance record for NEOGENESYS 2K, a class II device, cleared for Sanexas Intl. GmbH on under FDA product code LIH (Interferential Current Therapy). FDA records list one 510(k) clearance for Sanexas Intl. GmbH. As of , FDA records show no recalls naming K022433.

Clearance record

Decision date
Received
(183 days to decision)
Product code
LIH Interferential Current Therapy
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Sanexas Intl. GmbH 200 NE Mulberry, Lee'S Summit MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LIH

Trailing 12 months

FDA records hold no clearances under product code LIH in the trailing twelve months.

FDA records show no clearances under product code LIH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260