Cleared Traditional

K850872 - PHYACTION 300, 360, 370, 390 & 391 ELEC-MUSCLE-STI (FDA 510(k) Clearance)

K850872 · Ketronic, Inc. · Physical Medicine device
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Jun 1985
Decision
97d
Days
-
Risk

K850872 is an FDA 510(k) clearance for the PHYACTION 300, 360, 370, 390 & 391 ELEC-MUSCLE-STI.

Submitted by Ketronic, Inc. (The Netherlands, NL). The FDA issued a Cleared decision on June 6, 1985 after a review of 97 days - within the typical 510(k) review window.

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 Ketronic, Inc. devices

Submission Details

510(k) Number K850872 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 01, 1985
Decision Date June 06, 1985
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -