THERMOPHORE ELECTRIC FOMENTATION UNIT— 510(k) K851237

Name: FDA 510(k) clearance K851237
Creator: U.S. Food and Drug Administration
Published: 1985-07-29

Substantially Equivalent

Battle Creek Equipment Co.

FDA 510(k) clearance K851237 for THERMOPHORE ELECTRIC FOMENTATION UNIT, Substantially Equivalent on 1985-07-29. Applicant: Battle Creek Equipment Co.. Device class: 2.

Clearance details

Applicant: Battle Creek Equipment Co.
Product code: Code IRT
Device class: Class 2
Regulation: 21 CFR 890.5740
Advisory panel: Physical Medicine
Date received: 1985-03-27
Decision date: 1985-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Battle Creek, MI, US

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Recent devices under product code IRT

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More clearances from Battle Creek Equipment Co.

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K882264 — BATTLE CREEK PILLOW1988-08-09
K863884 — PULSESTAR EXERCISE BIKE1986-10-23
K854147 — BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL1985-12-27
K854148 — BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL1985-12-17
K840280 — ROAD RUNNER ELECTRIC TREADMILL1984-02-04

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.