ZIPPY, MODEL I88WA— 510(k) K012846

Substantially Equivalent

Pillar Technology, Inc.

FDA 510(k) clearance K012846 for ZIPPY, MODEL I88WA, Substantially Equivalent on 2001-11-20. Applicant: Pillar Technology, Inc..

Clearance details

Applicant: Pillar Technology, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2001-08-23
Decision date: 2001-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neodesha, KS, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.