The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co., Ltd. with the FDA for Smart Pain Reliever, Model Lt5019.
| Device ID | K162479 |
| 510k Number | K162479 |
| Device Name: | Smart Pain Reliever, Model LT5019 |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. NO. 3 BUILDING XILIBAIMANG XUSHENG INDUSTRIAL ESTATE NANSHAN Shenzhen, CN 518108 |
| Contact | Truman Shen |
| Correspondent | Truman Shen SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. NO. 3 BUILDING XILIBAIMANG XUSHENG INDUSTRIAL ESTATE NANSHAN Shenzhen, CN 518108 |
| Product Code | NUH |
| Subsequent Product Code | NGX |
| Subsequent Product Code | NYN |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-06 |
| Decision Date | 2017-02-08 |
| Summary: | summary |