Cleared Traditional

K844617 - EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE

K844617 is an FDA 510(k) clearance for EXCEL TECH MST-7 ISOELECTRONIC THERAPY ..., manufactured by Excel Tech. , Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K844617 · Excel Tech. , Ltd. · Physical Medicine device
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Mar 1985
Decision
98d
Days
Class 2
Risk

K844617 is an FDA 510(k) clearance for the EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville,Ontario, CA). The FDA issued a Cleared decision on March 5, 1985 after a review of 98 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K844617

510(k) Number K844617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1984
Decision Date March 05, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 116d · This submission: 98d
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 547
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K844617.
SINUS AC-POWERED MUSCLE STIMULATOR
K850453 · Zimmer Elektromedizin GmbH · May 1985
SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR
K850013 · Mettler Electronics Corp. · Apr 1985
ELECTRONIC MUSCLE STIMULATOR
K844489 · Beverly Hills Exercise Equipment · Mar 1985
SANYO ELECTRONIC MUSCLE STIMULATORS
K850047 · General Physiotherapy, Inc. · Mar 1985
MEDCOLATOR MODEL HVX
K844580 · Medco Products, Co., Inc. · Feb 1985
THE PROBE 100
K844466 · Rich-Mar Corp. · Feb 1985
K844617 · EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE
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