The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Lifecare Electrodes.
| Device ID | K083302 |
| 510k Number | K083302 |
| Device Name: | LIFECARE ELECTRODES |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-10 |
| Decision Date | 2009-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30816924020120 | K083302 | 000 |
| 30816924020083 | K083302 | 000 |
| 30816924020076 | K083302 | 000 |
| 20816924020062 | K083302 | 000 |
| 20816924020048 | K083302 | 000 |