# K022433: Neogenesys 2K

- Pathway: 510(k) (Traditional)
- Applicant: Sanexas Intl. GmbH
- Decided: Jan 24, 2003 after 183 days
- Product code: LIH (Interferential Current Therapy)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930263 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930263: Matrix Pro-Elecdt, Matrix Electromedical, Inc. (1994) Summary page 1.

## Indications for use
PAIN MANAGEMENT Indications for Electromedical Treatment 1. For adjunctive treatment of post-traumatic pain syndromes. 2. For management and symptomatic relief of chronic (long-term) intractable pain. 3. As an adjunctive treatment in the management of post-surgical pain problems. MUSCLE STIMULATION Indications for Electromedical Treatment 1. Relaxation of muscle spasms. 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle reeducation 5. Immediate post-surgical stimulation of calf muscle to prevent phlebothrombosis. 6. Maintaining or increasing range of motion Powered Muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

Source page: https://510kreport.com/device/K022433
Methodology: https://510kreport.com/methodology