K131259

Substantially Equivalent

LASER-STIM

Applicant: Shenzhen Dongdixin Technology Co., Ltd.
Product code: ILY
Advisory panel: Physical Medicine
Date received: 2013-05-02
Decision date: 2013-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, Guangdong, CN

Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.