510(k) K210364
- Device
- Migraine Tens Digital Pain Reliever
- Applicant
- Shenzhen Dongdixin Technology Co., Ltd.
- 510(k) number
- K210364
- Product code
- PCC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-06-17
- Date received
- 2021-02-08
- Regulation
- 882.5891
- Classification name
- Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Siping Yuan
- Address
- Floor 1-2, #3 Bldg., Fanshen Xusheng Industrial Estate Xilixiaobaimang, Nanshan District Shenzhen CN 518108 518108
FDA Registration Numbers#
- 3005170249
- 3042190125
- 3010188009
- 3015088397
- 3012316249
- 3015946733
- 3016856381
- 3040334342
- 3019551144
- 3014649088
- 3014389257
- 3003927385
Source Documents#
Other 510(k) Records For Product Code PCC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254216 | Enso for Migraine | Hinge Health, Inc. | 2026-04-16 |
| K242719 | ELEXIR 2.0 (ALLIVE3) | Nu Eyne Co., Ltd. | 2024-11-06 |
| K234029 | CEFALY Connected - OTC, CEFALY Connected - Rx | Cefaly Technology | 2024-07-18 |
| K232749 | DOOPANG | Ybrain, Inc. | 2024-06-11 |
| K233751 | Milieve (YPS-301BD) | Soterix Medical, Inc. | 2024-06-03 |
| K230782 | TENS device-HeadaTerm 2 (Model: YF-HT2) | Wat Medical Technology, Inc. | 2024-02-26 |
| K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx | Cefaly Technology | 2022-12-13 |
| K212106 | Relivion | Neurolief , Ltd. | 2021-08-02 |
| K211380 | Elexir | Nu Eyne Co., Ltd. | 2021-07-30 |
| K203419 | Relivion | Neurolief , Ltd. | 2021-02-16 |
| K201895 | Cefaly Dual | Cefaly Technology | 2020-09-29 |
| K192773 | ALLIVE | Nu Eyne Co., Ltd. | 2019-12-06 |
| K172450 | TENS device-HeadaTerm, eEspress | Wat Medical Technology (Ningbo) Co., Ltd. | 2018-09-13 |
| K173006 | Cefaly Dual | Cefaly Technology | 2017-11-28 |
| K171446 | Cefaly Acute | Cefaly Technology | 2017-09-15 |
Legacy Summary#
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FDA Review#
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