The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co., Ltd. with the FDA for Migraine Tens Digital Pain Reliever.
| Device ID | K210364 |
| 510k Number | K210364 |
| Device Name: | Migraine Tens Digital Pain Reliever |
| Classification | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Applicant | Shenzhen Dongdixin Technology Co., Ltd. Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang Nanshan District Shenzhen, CN 518108 |
| Contact | Siping Yuan |
| Correspondent | Siping Yuan Shenzhen Dongdixin Technology Co., Ltd. Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang Nanshan District Shenzhen, CN 518108 |
| Product Code | PCC |
| CFR Regulation Number | 882.5891 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-08 |
| Decision Date | 2021-06-17 |