Cleared Traditional

K972055 - MSI MAGNA-STYM

K972055 is an FDA 510(k) clearance for MSI MAGNA-STYM, manufactured by Microvas Systems, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K972055 · Microvas Systems, Inc. · Physical Medicine device
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Aug 1997
Decision
88d
Days
Class 2
Risk

K972055 is an FDA 510(k) clearance for the MSI MAGNA-STYM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Microvas Systems, Inc. (San Antonio, US). The FDA issued a Cleared decision on August 29, 1997 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Microvas Systems, Inc. devices

FDA 510(k) Submission Details - K972055

510(k) Number K972055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1997
Decision Date August 29, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
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 196
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K972055.
AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION
K972997 · Dan Med, Inc. · Nov 1997
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
K964434 · Skylark Device Co., Ltd. · Oct 1997
IMPULSE HVG
K970847 · Armstrong Industries, Inc. · Sep 1997
ORTHO DX NEUROMUSCULAR STIMULATOR
K971542 · Rehabilicare, Inc. · Aug 1997
NEURO-TRAIN II (2)
K970155 · Sterne Equipment Co., Ltd. · Mar 1997
SYS STIM 226
K964028 · Mettler Electronics Corp. · Feb 1997