The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Stimate N601 Tens.
| Device ID | K003487 |
| 510k Number | K003487 |
| Device Name: | STIMATE N601 TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 2FL NO. 1-2 TSAO TI WEI, SHEN KENG HSIANG Taipei Hsien,, TW |
| Contact | Dora Hsu Yang |
| Correspondent | Hsu Chang CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL BLDG. 16, 321 KUANG FU RD,SEC2 Hsinchu,, TW |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-11-13 |
| Decision Date | 2001-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060488570940 | K003487 | 000 |
| 10816924020294 | K003487 | 000 |
| 10816924020232 | K003487 | 000 |
| 10850209007013 | K003487 | 000 |