The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Everyway Incontinence Stimulation System.
| Device ID | K213116 |
| 510k Number | K213116 |
| Device Name: | Everyway Incontinence Stimulation System |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | Everyway Medical Instruments Co., Ltd. 3FL., No. 5, Lane 155, Section 3, Beishen Rd., Shenkeng District, New Taipei City, CN 22203 |
| Contact | Paul Hung |
| Correspondent | Paul Hung Everyway Medical Instruments Co., Ltd. 3FL., No. 5, Lane 155, Section 3, Beishen Rd., Shenkeng District, New Taipei City, CN 22203 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-27 |
| Decision Date | 2021-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871185575 | K213116 | 000 |
| 04719871185056 | K213116 | 000 |
| 04719871184189 | K213116 | 000 |
| 04719871183168 | K213116 | 000 |
| 04719871185070 | K213116 | 000 |