Cleared Traditional

K850851 - G5 APPARATUS T

K850851 is the FDA 510(k) clearance for G5 APPARATUS T by Physio Technology, Inc.. It is a Class 1 Physical Medicine device (product code ISA) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K850851 · Physio Technology, Inc. · Physical Medicine device
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Jun 1985
Decision
116d
Days
Class 1
Risk

K850851 is an FDA 510(k) clearance for the G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Physio Technology, Inc. (Topeka, US). The FDA issued a Cleared decision on June 25, 1985 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - the FDA physical medicine device framework. 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 Physio Technology, Inc. devices

Submission Details

510(k) Number K850851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date June 25, 1985
Days to Decision 116 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
1d slower than avg
Panel avg: 115d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ISA Massager, Therapeutic, Electric

All 15
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