Cleared Traditional

FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917

K924023 · Ferno · Physical Medicine
Apr 1993
Decision
246d
Days
Class 1
Risk

About This 510(k) Submission

K924023 is an FDA 510(k) clearance for the FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917, a Unit, Heating, Powered (Class I — General Controls, product code IRQ), submitted by Ferno (Wilmington, US). The FDA issued a Cleared decision on April 14, 1993, 246 days after receiving the submission on August 11, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5950.

Submission Details

510(k) Number K924023 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1992
Decision Date April 14, 1993
Days to Decision 246 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code IRQ — Unit, Heating, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5950

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