ZIP'R3/ ZIP'R3 XTRA SCOOTER— 510(k) K102358

Substantially Equivalent

Global Fabtech Wheelchair (Shanghai) Co., Ltd.

FDA 510(k) clearance K102358 for ZIP'R3/ ZIP'R3 XTRA SCOOTER, Substantially Equivalent on 2010-10-04. Applicant: Global Fabtech Wheelchair (Shanghai) Co., Ltd..

Clearance details

Applicant: Global Fabtech Wheelchair (Shanghai) Co., Ltd.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2010-08-19
Decision date: 2010-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

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.