Migraine Tens Digital Pain Reliever— 510(k) K210364

Name: FDA 510(k) clearance K210364
Creator: U.S. Food and Drug Administration
Published: 2021-06-17

Substantially Equivalent

Shenzhen Dongdixin Technology Co., Ltd.

FDA 510(k) clearance K210364 for Migraine Tens Digital Pain Reliever, Substantially Equivalent on 2021-06-17. Applicant: Shenzhen Dongdixin Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Dongdixin Technology Co., Ltd.
Product code: Code PCC
Device class: Class 2
Regulation: 21 CFR 882.5891
Advisory panel: Neurology
Date received: 2021-02-08
Decision date: 2021-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PCC

product code PCC

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.