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510(k) K210364

Migraine Tens Digital Pain Reliever by Shenzhen Dongdixin Technology Co., Ltd. — Product Code PCC

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.

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