THERMO TRIM— 510(k) K852637

Substantially Equivalent

Suntec Health & Fitness Group, Inc.

FDA 510(k) clearance K852637 for THERMO TRIM, Substantially Equivalent on 1985-11-20. Applicant: Suntec Health & Fitness Group, Inc..

Clearance details

Applicant: Suntec Health & Fitness Group, Inc.
Product code: Code IRT
Advisory panel: Physical Medicine
Date received: 1985-06-20
Decision date: 1985-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westport, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IRT

product code IRT

Injury: 668
Total: 668

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.