IMNI HOT PACKS— 510(k) K955788

Name: FDA 510(k) clearance K955788
Creator: U.S. Food and Drug Administration
Published: 1996-09-04

Substantially Equivalent

Omni Therm, Inc.

FDA 510(k) clearance K955788 for IMNI HOT PACKS, Substantially Equivalent on 1996-09-04. Applicant: Omni Therm, Inc.. Device class: 1.

Clearance details

Applicant: Omni Therm, Inc.
Product code: Code IMD
Device class: Class 1
Regulation: 21 CFR 890.5710
Advisory panel: Physical Medicine
Date received: 1995-12-22
Decision date: 1996-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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K961176 — OMNI COLD GEL PACKS1996-09-04
K954877 — OMNI COLD GEL PACKS1996-02-13
K936084 — OMNI WARM GEL PACKS1994-03-31
K864853 — OMNI THERM TEMPERATURE MONITOR1987-02-04

Adverse events under product code IMD

product code IMD

Death: 3
Injury: 600
Total: 603

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.