Cleared Traditional

K903497 - FLEXCOMP DSP & PROCOMP

K903497 is an FDA 510(k) clearance for FLEXCOMP DSP & PROCOMP, manufactured by Thought Technology , Ltd.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K903497 · Thought Technology , Ltd. · Neurology device
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Feb 1991
Decision
193d
Days
Class 2
Risk

K903497 is an FDA 510(k) clearance for the FLEXCOMP DSP & PROCOMP. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Thought Technology , Ltd. (Montreal, Quebec, CA). The FDA issued a Cleared decision on February 12, 1991 after a review of 193 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K903497

510(k) Number K903497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1990
Decision Date February 12, 1991
Days to Decision 193 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 149d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 Neurology devices follow this clearance model.

Regulatory Peers - HCC Device, Biofeedback

All 172
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K903497.
PATHWAY II ELECTROMYOGRAPH
K897132 · The Prometheus Group · Apr 1991
MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002
K905372 · Bio-Feedback Systems, Inc. · Apr 1991
MINIATURE TEMPERATURE TRAINER MODEL DT-002
K905373 · Bio-Feedback Systems, Inc. · Apr 1991
BODYLOG ENHANCED STRESS REDUCTION PACKAGE
K902450 · Bodylog, Inc. · Jan 1991
M(3):MICRO MUSCLE MONITOR
K896409 · Thought Technology , Ltd. · Oct 1990
DYNATRON 350 EMG/BIOFEEDBACK ANALYZER
K900639 · Dynatronics Laser Corp. · Oct 1990
K903497 · FLEXCOMP DSP & PROCOMP
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