higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)— 510(k) K172739

Substantially Equivalent

Higi Sh, LLC

FDA 510(k) clearance K172739 for higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing), Substantially Equivalent on 2017-10-10. Applicant: Higi Sh, LLC.

Clearance details

Applicant: Higi Sh, LLC
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2017-09-12
Decision date: 2017-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.