Cleared Traditional

K870793 - SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE

K870793 is an FDA 510(k) clearance for SELF REGULATION SYS PROF SERIES BIOFEED..., manufactured by Self Regulation Systems, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K870793 · Self Regulation Systems, Inc. · Neurology device
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May 1987
Decision
64d
Days
Class 2
Risk

K870793 is an FDA 510(k) clearance for the SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Self Regulation Systems, Inc. (Redmond, US). The FDA issued a Cleared decision on May 1, 1987 after a review of 64 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 Self Regulation Systems, Inc. devices

FDA 510(k) Submission Details - K870793

510(k) Number K870793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1987
Decision Date May 01, 1987
Days to Decision 64 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 148d · This submission: 64d
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 K870793.
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