Cleared Traditional

K834110 - ANTENSE ANTI-TENSION DEVICE

K834110 is an FDA 510(k) clearance for ANTENSE ANTI-TENSION DEVICE, manufactured by Bio Sig Instruments, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K834110 · Bio Sig Instruments, Inc. · Neurology device
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Feb 1984
Decision
67d
Days
Class 2
Risk

K834110 is an FDA 510(k) clearance for the ANTENSE ANTI-TENSION DEVICE. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Bio Sig Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 67 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.

View all Bio Sig Instruments, Inc. devices

FDA 510(k) Submission Details - K834110

510(k) Number K834110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1983
Decision Date February 04, 1984
Days to Decision 67 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 148d · This submission: 67d
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 57
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K834110.
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