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 Combination Stimulator.
| Device ID | K201335 |
| 510k Number | K201335 |
| Device Name: | Li-Battery Powered OTC TENS/EMS Combination Stimulator |
| 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, TW 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, TW 22203 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-20 |
| Decision Date | 2020-10-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871184066 | K201335 | 000 |
| 04719871183618 | K201335 | 000 |
| 04719871189337 | K201335 | 000 |
| 04719871185131 | K201335 | 000 |