510(k) K210364
K210364 is an FDA 510(k) premarket notification submitted by Shenzhen Dongdixin Technology Co., Ltd. for the device "Migraine Tens Digital Pain Reliever". The FDA issued a decision of Substantially Equivalent on June 17, 2021. The device falls under product code PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine), a Class II device regulated under 21 CFR 882.5891. Shenzhen Dongdixin Technology Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2021
- Date Received
- February 8, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
- Device Class
- Class II
- Regulation Number
- 882.5891
- Review Panel
- NE
- Submission Type
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.