The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Li-battery Powered Otc Tens/ems, Model Em-6000, Em-6100, Em-6200 & Em-6300.
| Device ID | K202470 |
| 510k Number | K202470 |
| Device Name: | Li-Battery Powered OTC TENS/EMS, Model EM-6000, EM-6100, EM-6200 & EM-6300 |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Everyway Medical Instruments Co., Ltd. 3FL., No. 5, Lane 155, Section 3, Peishen 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, Peishen Rd., Shenkeng District, New Taipei City, CN 22203 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-28 |
| Decision Date | 2020-11-25 |