Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK— 510(k) K181541

Substantially Equivalent

Andon Health Co, Ltd.

FDA 510(k) clearance K181541 for Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK, Substantially Equivalent on 2019-04-16. Applicant: Andon Health Co, Ltd..

Clearance details

Applicant: Andon Health Co, Ltd.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2018-06-11
Decision date: 2019-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianjin, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.