The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Lifecare 5*5 Cm Square, Lifecare 4*4 Cm Square, Lifecare 5 Cm Round, Lifecare 7.5 Cm Round, Lifecare 4*6 Cm Oval.
| Device ID | K012463 |
| 510k Number | K012463 |
| Device Name: | LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL |
| Classification | Electrode, Cutaneous |
| Applicant | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3 FL.NO.5 LN.155 BEI-SHEND RD. SEC. 3 Shen Keng Hsiang,taipei Hsien, TW 222 |
| Contact | Robert Tu |
| Correspondent | Robert Tu EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3 FL.NO.5 LN.155 BEI-SHEND RD. SEC. 3 Shen Keng Hsiang,taipei Hsien, TW 222 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-01 |
| Decision Date | 2002-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816924020321 | K012463 | 000 |
| 05060488570957 | K012463 | 000 |
| 05060488570964 | K012463 | 000 |
| 05060488570971 | K012463 | 000 |
| 05060488570988 | K012463 | 000 |
| 30816924020137 | K012463 | 000 |
| 00816924020143 | K012463 | 000 |
| 30816924020175 | K012463 | 000 |
| 30816924020182 | K012463 | 000 |
| 30816924020199 | K012463 | 000 |
| 30816924020205 | K012463 | 000 |
| 30816924020229 | K012463 | 000 |
| 30850209007000 | K012463 | 000 |