Cleared Traditional

K834519 - CALMTONE

K834519 is an FDA 510(k) clearance for CALMTONE, 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 40-day FDA review.

K834519 · Thought Technology , Ltd. · Neurology device
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Jan 1984
Decision
40d
Days
Class 2
Risk

K834519 is an FDA 510(k) clearance for the CALMTONE. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Thought Technology , Ltd. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 40 days - a notably fast clearance 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: 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 - K834519

510(k) Number K834519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1983
Decision Date January 30, 1984
Days to Decision 40 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
109d faster than avg
Panel avg: 149d · This submission: 40d
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 K834519.
ORION BIOFEEDBACK DATA ACQUISITION
K840223 · Self Regulation Systems, Inc. · Mar 1984
ANTENSE ANTI-TENSION DEVICE
K834110 · Bio Sig Instruments, Inc. · Feb 1984
ANTACHE ANTI-HEADACHE DEVICE
K834111 · Bio Sig Instruments, Inc. · Feb 1984
VERIMED MYOEXORCISER
K832714 · Verimed Holdings, Inc. · Oct 1983
FEEDBACK EMG SYSTEM PE-020
K832333 · Bio-Feedback Systems, Inc. · Sep 1983
TA-400 TEMP. FEEDBACK DEVICE
K832146 · Spectral Data Systems · Aug 1983
K834519 · CALMTONE
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