The following data is part of a premarket notification filed by Easymed Instrument Co., Ltd. with the FDA for Smarttens.
| Device ID | K143430 |
| 510k Number | K143430 |
| Device Name: | SmartTENS |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | EASYMED INSTRUMENT CO., LTD. 5/F-6/F, BLOCK A, GUPO GONGMAO BLDG FENGXIN ROAD, FENGXIANG INDUSTRIAL DISTRICT Daliang, Shunde, Foshan, Guang Dong, CN 528300 |
| Contact | Jeffery Wu(tingjie Wu) |
| Correspondent | Jeffery Wu(tingjie Wu) EASYMED INSTRUMENT CO., LTD. 5/F-6/F, BLOCK A, GUPO GONGMAO BLDG FENGXIN ROAD, FENGXIANG INDUSTRIAL DISTRICT Daliang, Shunde, Foshan, Guang Dong, CN 528300 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-01 |
| Decision Date | 2015-05-29 |
| Summary: | summary |