The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Life-care Vaginal Probe Life-care Anal Probe.
| Device ID | K122194 |
| 510k Number | K122194 |
| Device Name: | LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3 FL., NO. 5, LANE 155, SEC.3, PEISHEN RD. Shen Keng Hsiang,taipei Hsien, TW 222 |
| Contact | Robert Tu |
| Correspondent | Robert Tu EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3 FL., NO. 5, LANE 155, SEC.3, PEISHEN RD. Shen Keng Hsiang,taipei Hsien, TW 222 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-24 |
| Decision Date | 2013-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871184844 | K122194 | 000 |
| 04719871184769 | K122194 | 000 |
| 04719871183977 | K122194 | 000 |
| 04719871183960 | K122194 | 000 |
| 04719871183441 | K122194 | 000 |
| 04719871183434 | K122194 | 000 |
| 04719871183427 | K122194 | 000 |
| 04719871183366 | K122194 | 000 |
| 04719871183359 | K122194 | 000 |
| 04719871183137 | K122194 | 000 |
| 04719871183120 | K122194 | 000 |
| 04719871183113 | K122194 | 000 |
| 04719871183090 | K122194 | 000 |
| 04719871183076 | K122194 | 000 |
| 04719871184776 | K122194 | 000 |
| 04719871184783 | K122194 | 000 |
| 04719871184790 | K122194 | 000 |
| 04719871183410 | K122194 | 000 |
| 04719871183403 | K122194 | 000 |
| 04719871183397 | K122194 | 000 |
| 04719871183380 | K122194 | 000 |
| 04719871183373 | K122194 | 000 |
| 04719871183106 | K122194 | 000 |
| 04719871183083 | K122194 | 000 |
| 04719871183069 | K122194 | 000 |
| 04719871183045 | K122194 | 000 |
| 04719871184837 | K122194 | 000 |
| 04719871184820 | K122194 | 000 |
| 04719871184813 | K122194 | 000 |
| 04719871184806 | K122194 | 000 |
| 04719871183052 | K122194 | 000 |