510(k) · Cleared
ClearedNeogenesys 2K
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanexas Intl. GmbH · LIH Interferential Current Therapy
Cleared on Jan 24, 2003 as substantially equivalent to K930263 (Matrix Electromedical, Inc., 1994) after a 183-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jan 24, 2003
- Review
- 183 days
- Class
- Class II
- Product code
- LIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930263 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK930263 Matrix Pro-ElecdtMatrix Electromedical, Inc. · 1994
- This deviceK022433 Neogenesys 2KSanexas Intl. GmbH · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930263 | Matrix Pro-Elecdt | Matrix Electromedical, Inc. | 1994 | — |
| 0 (this device) | K022433 | Neogenesys 2K | Sanexas Intl. GmbH | 2003 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LIH device
- #1 K231575 Vecttor VT-300score 7.1 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K930263 | Matrix Pro-ElecdtSummary page 1…Therapy device, Product Code LIH (Unclassified), IPF, GZJ The legally marketed device to which our firm is claiming equivalence is the ProElecDT, K930263. [807.92(a)(3)]. Description and Intended Use [807.92(a)(4)] and [807.92(a)(5)] This device is an electrical signal ge… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All LIH devicesLIH Interferential Current Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LIH
Too few LIH 510(k)s in any year since 2007 to give a median.
Recalls per year · LIH
No recall names LIH since 2007.
Adverse event reports per year · LIH
1in 2025
MAUDE reports naming product code LIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 2 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (101 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022433 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022433: Neogenesys 2K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022433
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026