CELSIUS CONTROL SYSTEM— 510(k) K022366

Substantially Equivalent

Innercool Therapies

FDA 510(k) clearance K022366 for CELSIUS CONTROL SYSTEM, Substantially Equivalent on 2003-01-27. Applicant: Innercool Therapies.

Clearance details

Applicant: Innercool Therapies
Product code: Code NCX
Advisory panel: Cardiovascular
Date received: 2002-07-22
Decision date: 2003-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego,, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NCX

product code NCX

Death: 30
Malfunction: 2,302
Total: 2,332

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.