The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for S Series Electrodes / Models S55105, S80120, Sg4040, Sg4368, Sg50d, Sg5050, Sg5075, Sg50100, Sg5795, Sg60147, Sg7090, & Sg75d.
| Device ID | K173186 |
| 510k Number | K173186 |
| Device Name: | S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D |
| Classification | Electrode, Cutaneous |
| Applicant | Everyway Medical Instruments Co., Ltd. 3Fl., No. 5, Lane 155, Sec. 3, Beishen Rd. Shenkeng Dist New Taipei City, TW 22203 |
| Contact | Paul Hung |
| Correspondent | Paul Hung Everyway Medical Instruments Co., Ltd. 3Fl., No. 5, Lane 155, Sec. 3, Beishen Rd. Shenkeng Dist New Taipei City, TW 22203 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-02 |
| Decision Date | 2018-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871185346 | K173186 | 000 |
| 04719871189283 | K173186 | 000 |
| 04719871189290 | K173186 | 000 |
| 04719871189306 | K173186 | 000 |
| 04719871189313 | K173186 | 000 |
| 04719871189269 | K173186 | 000 |
| 04719871183656 | K173186 | 000 |
| 04719871184202 | K173186 | 000 |
| 04719871184219 | K173186 | 000 |
| 04719871184325 | K173186 | 000 |
| 04719871184332 | K173186 | 000 |
| 04719871189276 | K173186 | 000 |