The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Lifecare Conductive Garments.
| Device ID | K103719 |
| 510k Number | K103719 |
| Device Name: | LIFECARE CONDUCTIVE GARMENTS |
| Classification | Electrode, Cutaneous |
| Applicant | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-21 |
| Decision Date | 2011-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871183342 | K103719 | 000 |
| 00857771003439 | K103719 | 000 |
| 00857771003347 | K103719 | 000 |
| 00850706007298 | K103719 | 000 |
| 00850706007236 | K103719 | 000 |
| 04719871183267 | K103719 | 000 |
| 04719871183274 | K103719 | 000 |
| 04719871183281 | K103719 | 000 |
| 04719871183298 | K103719 | 000 |
| 04719871183304 | K103719 | 000 |
| 04719871183311 | K103719 | 000 |
| 04719871183328 | K103719 | 000 |
| 04719871183335 | K103719 | 000 |
| 00850706007014 | K103719 | 000 |