The following data is part of a premarket notification filed by Sanexas Intl. Gmbh with the FDA for Neogenesys 2k.
| Device ID | K022433 |
| 510k Number | K022433 |
| Device Name: | NEOGENESYS 2K |
| Classification | Interferential Current Therapy |
| Applicant | SANEXAS INTL. GMBH 200 NE MULBERRY Lee's Summit, MO 64086 |
| Contact | Gene Kelly |
| Correspondent | Gene Kelly SANEXAS INTL. GMBH 200 NE MULBERRY Lee's Summit, MO 64086 |
| Product Code | LIH |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | IPF |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-25 |
| Decision Date | 2003-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000214018 | K022433 | 000 |
| 00860000214001 | K022433 | 000 |
| 00860000214049 | K022433 | 000 |
| 00860000214032 | K022433 | 000 |