Cleared Traditional

K954127 - BIOFEEDBACK DEVICE

K954127 is an FDA 510(k) clearance for BIOFEEDBACK DEVICE, manufactured by Verimed Holdings, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K954127 · Verimed Holdings, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
75d
Days
Class 2
Risk

K954127 is an FDA 510(k) clearance for the BIOFEEDBACK DEVICE. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Verimed Holdings, Inc. (Coral Springs, US). The FDA issued a Cleared decision on November 14, 1995 after a review of 75 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 - K954127

510(k) Number K954127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1995
Decision Date November 14, 1995
Days to Decision 75 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 149d · This submission: 75d
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 K954127.
AT53 DUAL CHANNEL EMG
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RELAXPLUS
K951213 · Ultramind International , Ltd. · Sep 1995
A620 EEG
K944615 · Stoelting Co. · Sep 1995
THE BAGNOLI-2 EMG SYSTEM
K945286 · Delsys, Inc. · Sep 1995
K954127 · BIOFEEDBACK DEVICE
Download PDF FDA Summary Verimed Holdings, Inc.