Cleared Traditional

K860271 - BIOFEEDBACK MICROLAB

K860271 is an FDA 510(k) clearance for BIOFEEDBACK MICROLAB, manufactured by Hrm Software/Div. of Human Relations Media. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K860271 · Hrm Software/Div. of Human Relations Media · Neurology device
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Jun 1986
Decision
142d
Days
Class 2
Risk

K860271 is an FDA 510(k) clearance for the BIOFEEDBACK MICROLAB. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Hrm Software/Div. of Human Relations Media (Pleasantville, US). The FDA issued a Cleared decision on June 18, 1986 after a review of 142 days - within the typical 510(k) review window.

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.

View all Hrm Software/Div. of Human Relations Media devices

FDA 510(k) Submission Details - K860271

510(k) Number K860271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1986
Decision Date June 18, 1986
Days to Decision 142 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 148d · This submission: 142d
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 K860271.
MYODAC2 BIOFEEDBACK DEVICE
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MYOTRAC
K881416 · Thought Technology , Ltd. · Sep 1988
TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA
K850642 · Thought Technology , Ltd. · May 1985
HR/BVP 100T HEART RATE MONITOR
K850643 · Thought Technology , Ltd. · May 1985
CALMTONE
K834519 · Thought Technology , Ltd. · Jan 1984