Cleared Traditional

K850851 - G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S

K850851 is an FDA 510(k) clearance for G5 APPARATUS T, manufactured by Physio Technology, Inc.. The device is a Class 1 Physical Medicine device with 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

FDA 510(k) Submission Details - K850851

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.

ISA Device Classification - Class 1, General Controls

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 28
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