The following data is part of a premarket notification filed by Easymed Instruments Co., Ltd. with the FDA for Easystim Tn28_otc.
| Device ID | K140168 |
| 510k Number | K140168 |
| Device Name: | EASYSTIM TN28_OTC |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | EASYMED INSTRUMENTS CO., LTD. 5/F- 6/F, Block A, Gupo Gongmao Building Fengxin Road, Fengxiang Industrial District Daliang, Shunde, Foshan, CN 528300 |
| Contact | Jeffery Wu |
| Correspondent | Jeffery Wu EASYMED INSTRUMENTS CO., LTD. 5/F- 6/F, Block A, Gupo Gongmao Building Fengxin Road, Fengxiang Industrial District Daliang, Shunde, Foshan, CN 528300 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-23 |
| Decision Date | 2014-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05033435132232 | K140168 | 000 |