Cleared Traditional

K922020 - ENDOMED 582

K922020 is an FDA 510(k) clearance for ENDOMED 582, manufactured by Henley Intl.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K922020 · Henley Intl. · Neurology device
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Sep 1992
Decision
145d
Days
Class 2
Risk

K922020 is an FDA 510(k) clearance for the ENDOMED 582. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on September 22, 1992 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Henley Intl. devices

FDA 510(k) Submission Details - K922020

510(k) Number K922020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1992
Decision Date September 22, 1992
Days to Decision 145 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 148d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIH Device Classification - Class 2, Special Controls

Product Code LIH Interferential Current Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - LIH Interferential Current Therapy

All 43
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K922020.
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DYNATRON 400
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MULTI III
K921953 · Excel Tech. , Ltd. · Aug 1992
ISOTRON III
K921954 · Excel Tech. , Ltd. · Aug 1992
INTERFERENTIAL STIMULATOR MODEL INF 4150/A
K921441 · Biomedical Life Systems, Inc. · May 1992