Cleared Traditional

K936148 - STRESS HANDLER

K936148 is an FDA 510(k) clearance for STRESS HANDLER, manufactured by Arocep Enterprises , Ltd.. The device is a Class 1 Physical Medicine device with product code LYG cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K936148 · Arocep Enterprises , Ltd. · Physical Medicine device
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Apr 1994
Decision
115d
Days
Class 1
Risk

K936148 is an FDA 510(k) clearance for the STRESS HANDLER. Classified as Massager, Therapeutic, Manual (product code LYG), Class I - General Controls.

Submitted by Arocep Enterprises , Ltd. (Brampton, Ontario, CA). The FDA issued a Cleared decision on April 21, 1994 after a review of 115 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 Arocep Enterprises , Ltd. devices

FDA 510(k) Submission Details - K936148

510(k) Number K936148 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 27, 1993
Decision Date April 21, 1994
Days to Decision 115 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
At panel average
Panel avg: 115d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

LYG Device Classification - Class 1, General Controls

Product Code LYG Massager, Therapeutic, Manual
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 - LYG Massager, Therapeutic, Manual

Devices cleared under the same product code (LYG) and FDA review panel - the closest regulatory comparables to K936148.
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