Cleared Traditional

K823146 - CALMSET 3 TM

K823146 is an FDA 510(k) clearance for CALMSET 3 TM, 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 39-day FDA review.

K823146 · Thought Technology , Ltd. · Neurology device
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Dec 1982
Decision
39d
Days
Class 2
Risk

K823146 is an FDA 510(k) clearance for the CALMSET 3 TM. 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 December 3, 1982 after a review of 39 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 - K823146

510(k) Number K823146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1982
Decision Date December 03, 1982
Days to Decision 39 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
110d faster than avg
Panel avg: 149d · This submission: 39d
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 K823146.
EMG BIOFEEDBACK DEVICE
K823511 · Nemectron Medical, Inc. · Mar 1983
BIOFEEDBACK-TRAINING INSTRUMENT
K830529 · Relaxomat, Inc. · Mar 1983
PROFESSIONAL MARK I BIOFEEDBACK SYS
K823381 · Srs Co. · Jan 1983
EMG 100T
K822814 · Thought Technology , Ltd. · Oct 1982
ISOLATED VOLTAGE/FREQUENCY CONVERTER
K812619 · Bio-Feedback Systems, Inc. · Oct 1981
LIFE-TECH #1753 BIOFEEDBACK TRAINER
K812179 · Life-Tech Instruments, Inc. · Aug 1981
K823146 · CALMSET 3 TM
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