Cleared Traditional

K946186 - CHAL-2500

K946186 is an FDA 510(k) clearance for CHAL-2500, manufactured by Hogan & Hartson. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K946186 · Hogan & Hartson · Physical Medicine device
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Aug 1995
Decision
237d
Days
Class 2
Risk

K946186 is an FDA 510(k) clearance for the CHAL-2500. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Hogan & Hartson (Washington, D.C., US). The FDA issued a Cleared decision on August 14, 1995 after a review of 237 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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 Hogan & Hartson devices

FDA 510(k) Submission Details - K946186

510(k) Number K946186 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 20, 1994
Decision Date August 14, 1995
Days to Decision 237 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
122d slower than avg
Panel avg: 115d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 158
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K946186.
ULTRA III
K960096 · Excel Tech. , Ltd. · Mar 1996
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K960489 · Excel Tech. , Ltd. · Mar 1996
FORTE ES-400
K953615 · Chattanooga Group, Inc. · Oct 1995
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
GALVANIC GENERATOR MODEL IMF4150/A
K932916 · Biomedical Life Systems, Inc. · Jan 1994
IF-II (TM), MODEL 7200
K923914 · Medical Devices, Inc. · Nov 1992