The following data is part of a premarket notification filed by Thought Technology Ltd. with the FDA for Myotrac Infiniti Electrical Stimulator.
| Device ID | K053434 |
| 510k Number | K053434 |
| Device Name: | MYOTRAC INFINITI ELECTRICAL STIMULATOR |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | THOUGHT TECHNOLOGY LTD. 2180 BELGRAVE AVE. Montreal, Quebec, CA H4a 2lb |
| Contact | Suresh R Sugirtharaja |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | KPI |
| Subsequent Product Code | HCC |
| Subsequent Product Code | IPF |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-12-09 |
| Decision Date | 2006-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540191000418 | K053434 | 000 |
| 07540191000401 | K053434 | 000 |
| 07540191000555 | K053434 | 000 |