QK-SYSTEMIC THERAPEUTIC APPARATUS— 510(k) K141892

Substantially Equivalent

Harbin Quanke Medi-Technical Development Co., Ltd.

FDA 510(k) clearance K141892 for QK-SYSTEMIC THERAPEUTIC APPARATUS, Substantially Equivalent on 2015-01-28. Applicant: Harbin Quanke Medi-Technical Development Co., Ltd..

Clearance details

Applicant: Harbin Quanke Medi-Technical Development Co., Ltd.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2014-07-14
Decision date: 2015-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harbin, Heilongjiang, CN

Download summary PDF View on FDA.gov ↗

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.