Cleared Traditional

K840036 - FITEX (FDA 510(k) Clearance)

K840036 · Britt Corp., Inc. · Physical Medicine device
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Oct 1984
Decision
295d
Days
-
Risk

K840036 is an FDA 510(k) clearance for the FITEX.

Submitted by Britt Corp., Inc. (Chanhassen, US). The FDA issued a Cleared decision on October 26, 1984 after a review of 295 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K840036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1984
Decision Date October 26, 1984
Days to Decision 295 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 115d · This submission: 295d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -