Neogenesys 2K

FDA 510(k) K022433 · Sanexas Intl. GmbH

Substantially Equivalent

510(k) numberK022433

Submission

Device name
Neogenesys 2K
Applicant
Sanexas Intl. GmbH
Lee'S Summit, MO, US
Received
July 25, 2002
Decision date
January 24, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LIH – Interferential Current Therapy
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

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Questions and answers

When was Neogenesys 2K cleared by the FDA?

Neogenesys 2K (K022433) received a 510(k) decision of Substantially Equivalent on January 24, 2003, 183 days after the submission was received.

What is the product code of K022433?

The FDA product code is LIH – Interferential Current Therapy, a Class II (moderate risk) device regulated under 21 CFR 882.5890.