XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248— 510(k) K040358

Substantially Equivalent

Excel Tech. , Ltd.

FDA 510(k) clearance K040358 for XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248, Substantially Equivalent on 2004-08-06. Applicant: Excel Tech. , Ltd..

Clearance details

Applicant: Excel Tech. , Ltd.
Product code: Code GWF
Advisory panel: Neurology
Date received: 2004-02-13
Decision date: 2004-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, Ontario, CA

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Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.