Cleared Traditional

K952683 - APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE

K952683 is an FDA 510(k) clearance for APEX MEDICAL CORP. PORTABLE INTERFERENT..., manufactured by Wholesale Medical Imports, Inc.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 659-day FDA review.

K952683 · Wholesale Medical Imports, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
659d
Days
Class 2
Risk

K952683 is an FDA 510(k) clearance for the APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Wholesale Medical Imports, Inc. (Great Neck,, US). The FDA issued a Cleared decision on April 1, 1997 after a review of 659 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Wholesale Medical Imports, Inc. devices

FDA 510(k) Submission Details - K952683

510(k) Number K952683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1995
Decision Date April 01, 1997
Days to Decision 659 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
511d slower than avg
Panel avg: 148d · This submission: 659d
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 42
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K952683.
SD-730 IF-SDS, PERFECT PULSE IF-SDS
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DYNATRON 525
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ISOTRON III, ISOTRON IV
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MULTI III, IV
K955860 · Excel Tech. , Ltd. · Mar 1996