Cleared Traditional

K980158 - MYO-TRAIN V (5)

K980158 is an FDA 510(k) clearance for MYO-TRAIN V (5), manufactured by Sterne Equipment Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K980158 · Sterne Equipment Co., Ltd. · Physical Medicine device
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Jul 1998
Decision
193d
Days
Class 2
Risk

K980158 is an FDA 510(k) clearance for the MYO-TRAIN V (5). Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Sterne Equipment Co., Ltd. (Brampton, On., CA). The FDA issued a Cleared decision on July 28, 1998 after a review of 193 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 Sterne Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K980158

510(k) Number K980158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1998
Decision Date July 28, 1998
Days to Decision 193 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
78d slower than avg
Panel avg: 115d · This submission: 193d
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 K980158.
FORTE, MODELS CPS 400 STIM, CPS 200 STIM
K982828 · Chattanooga Group, Inc. · Nov 1998
HANDMASTER NMS1
K982482 · N.E.S.S. Nuromuscular Electrical Stimulation Syst · Sep 1998
SURGI STIM
K982388 · Vision Quest Industries, Inc. · Sep 1998
ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D
K980040 · Nisha Communication Industries · Jul 1998
NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM
K973929 · Neotonus, Inc. · May 1998
HAKOMED ELECDT / PRO ELEDT SERIES
K980892 · Alive, Inc. · May 1998