The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co.,ltd. with the FDA for Wireless Pain Relieve Device.
| Device ID | K180331 |
| 510k Number | K180331 |
| Device Name: | Wireless Pain Relieve Device |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Shenzhen Dongdixin Technology Co.,Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate, Nansha Shenzhen, CN 518108 |
| Contact | Siping Yuan |
| Correspondent | Siping Yuan Shenzhen Dongdixin Technology Co.,Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate, Nansha Shenzhen, CN 518108 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-06 |
| Decision Date | 2018-06-22 |
| Summary: | summary |