Cleared Traditional

K912328 - ELECTRONIC MUSCLE STIMULATORS, EXCEL II, MODIFIED

K912328 is an FDA 510(k) clearance for ELECTRONIC MUSCLE STIMULATORS, manufactured by Advanced Rehabilitative Technology, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 532-day FDA review.

K912328 · Advanced Rehabilitative Technology, Inc. · Physical Medicine device
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Nov 1992
Decision
532d
Days
Class 2
Risk

K912328 is an FDA 510(k) clearance for the ELECTRONIC MUSCLE STIMULATORS, EXCEL II, MODIFIED. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Advanced Rehabilitative Technology, Inc. (San Antonio, US). The FDA issued a Cleared decision on November 6, 1992 after a review of 532 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Physical Medicine submissions.

View all Advanced Rehabilitative Technology, Inc. devices

FDA 510(k) Submission Details - K912328

510(k) Number K912328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1991
Decision Date November 06, 1992
Days to Decision 532 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
417d slower than avg
Panel avg: 115d · This submission: 532d
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 273
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K912328.
DYNATRON 250
K944935 · Dynatronics Corp. · Jun 1995
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
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K932916 · Biomedical Life Systems, Inc. · Jan 1994
IF-II (TM), MODEL 7200
K923914 · Medical Devices, Inc. · Nov 1992
RICH-MAR HV 1000 MUSCLE STIMULATOR
K920833 · Rich-Mar Corp. · May 1992
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436 · Medtronic Vascular · May 1992