THERMOWRAP, A/K/A/, THERMAL WRAP— 510(k) K873254

Name: FDA 510(k) clearance K873254
Creator: U.S. Food and Drug Administration
Published: 1987-12-11

Substantially Equivalent

Family Sun Tanning

FDA 510(k) clearance K873254 for THERMOWRAP, A/K/A/, THERMAL WRAP, Substantially Equivalent on 1987-12-11. Applicant: Family Sun Tanning. Device class: 2.

Clearance details

Applicant: Family Sun Tanning
Product code: Code IRT
Device class: Class 2
Regulation: 21 CFR 890.5740
Advisory panel: Physical Medicine
Date received: 1987-08-17
Decision date: 1987-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westminster, CA, US

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Recent devices under product code IRT

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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.