Cleared Traditional

K982388 - SURGI STIM

K982388 is an FDA 510(k) clearance for SURGI STIM, manufactured by Vision Quest Industries, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K982388 · Vision Quest Industries, Inc. · Physical Medicine device
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Sep 1998
Decision
67d
Days
Class 2
Risk

K982388 is an FDA 510(k) clearance for the SURGI STIM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Vision Quest Industries, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on September 14, 1998 after a review of 67 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.

FDA 510(k) Submission Details - K982388

510(k) Number K982388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1998
Decision Date September 14, 1998
Days to Decision 67 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
49d faster than avg
Panel avg: 116d · This submission: 67d
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 370
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K982388.
MS400
K984113 · Lsi Intl., Inc. · Jan 1999
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K982828 · Chattanooga Group, Inc. · Nov 1998
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K982482 · N.E.S.S. Nuromuscular Electrical Stimulation Syst · Sep 1998
MYO-TRAIN V (5)
K980158 · Sterne Equipment Co., Ltd. · Jul 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
K982388 · SURGI STIM
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