The following data is part of a premarket notification filed by Neurotron Medical with the FDA for Theraknit Garment Electrode.
| Device ID | K053214 |
| 510k Number | K053214 |
| Device Name: | THERAKNIT GARMENT ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | NEUROTRON MEDICAL 800 SILVIA ST. Ewing, NJ 08628 |
| Contact | Jack Guldalian |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-11-17 |
| Decision Date | 2005-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B1870780 | K053214 | 000 |
| B1870070 | K053214 | 000 |
| B1870090 | K053214 | 000 |
| B1870111 | K053214 | 000 |
| B1870121 | K053214 | 000 |
| B1870141 | K053214 | 000 |
| B1870261 | K053214 | 000 |
| B1870271 | K053214 | 000 |
| B1870282 | K053214 | 000 |
| B1870290 | K053214 | 000 |
| B1870300 | K053214 | 000 |
| B1870311 | K053214 | 000 |
| B1870321 | K053214 | 000 |
| B1870331 | K053214 | 000 |
| B1870341 | K053214 | 000 |
| B1870060 | K053214 | 000 |
| B1870050 | K053214 | 000 |
| B1870770 | K053214 | 000 |
| B1870760 | K053214 | 000 |
| B1870750 | K053214 | 000 |
| B1870740 | K053214 | 000 |
| 00857771003354 | K053214 | 000 |
| 00857771003385 | K053214 | 000 |
| B1900681 | K053214 | 000 |
| B1900700 | K053214 | 000 |
| B1900710 | K053214 | 000 |
| B1900720 | K053214 | 000 |
| B1900730 | K053214 | 000 |
| B1870080 | K053214 | 000 |
| B1870010 | K053214 | 000 |
| B1870020 | K053214 | 000 |
| B1870351 | K053214 | 000 |
| B1870361 | K053214 | 000 |
| B1870371 | K053214 | 000 |
| B1870660 | K053214 | 000 |
| B1870670 | K053214 | 000 |
| 00850706007038 | K053214 | 000 |
| 00857771003408 | K053214 | 000 |
| 00857771003415 | K053214 | 000 |
| 00857771003521 | K053214 | 000 |
| 00857771003538 | K053214 | 000 |
| 00857771003545 | K053214 | 000 |
| 00857771003552 | K053214 | 000 |
| 00857771003620 | K053214 | 000 |
| 00857771003637 | K053214 | 000 |
| 00857771003644 | K053214 | 000 |
| 00857771003651 | K053214 | 000 |
| 00857771003668 | K053214 | 000 |
| B1870651 | K053214 | 000 |
| B1870641 | K053214 | 000 |
| B1870390 | K053214 | 000 |
| B1870400 | K053214 | 000 |
| B1870412 | K053214 | 000 |
| B1870421 | K053214 | 000 |
| B1870430 | K053214 | 000 |
| B1870441 | K053214 | 000 |
| B1870450 | K053214 | 000 |
| B1870460 | K053214 | 000 |
| B1870480 | K053214 | 000 |
| B1870490 | K053214 | 000 |
| B1870501 | K053214 | 000 |
| B1870511 | K053214 | 000 |
| B1870611 | K053214 | 000 |
| B1870631 | K053214 | 000 |
| 00857771003675 | K053214 | 000 |