Cleared Traditional

K852034 - VITATRON M

K852034 · Elmed, Inc. · Physical Medicine device
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Jan 1986
Decision
239d
Days
-
Risk

K852034 is an FDA 510(k) clearance for the VITATRON M.

Submitted by Elmed, Inc. (Addison, US). The FDA issued a Cleared decision on January 3, 1986 after a review of 239 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.

View all Elmed, Inc. devices

FDA 510(k) Submission Details - K852034

510(k) Number K852034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1985
Decision Date January 03, 1986
Days to Decision 239 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 115d · This submission: 239d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -