Cleared Traditional

K941938 - THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE

K941938 is an FDA 510(k) clearance for THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE, manufactured by Intercare Diagnostics, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K941938 · Intercare Diagnostics, Inc. · Neurology device

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Aug 1994

Decision

106d

Days

Class 2

Risk

K941938 is an FDA 510(k) clearance for the THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Intercare Diagnostics, Inc. (Inglewood, US). The FDA issued a Cleared decision on August 5, 1994 after a review of 106 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.

FDA 510(k) Submission Details - K941938

510(k) Number	K941938 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 21, 1994
Decision Date	August 05, 1994
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

43d faster than avg

Panel avg: 149d · This submission: 106d

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 K941938.

RELAXOMAT

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K935853 · Unitech · Jan 1995

PHYSIOTECH 4000 OR NORODYN 8000

K922270 · Myo-Tronics, Inc. · Sep 1994

MEDAC SYSTEM/3

K914925 · Davicon, Inc. · Oct 1993

NORODYN 2000 ELECTROMYOGRAPH

K922838 · Noromed, Inc. · Sep 1993

PSI 220 DUAL EMG

K925197 · Fasstech · Feb 1993

FDA 510(k) Resources - Neurology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K941938

Intercare Diagnostics, Inc.

Inglewood, CA · US

ANTHONY DIKE

Regulatory profile

5 submissions 5 cleared

100% clearance rate · Active in Neurology

View all devices by Intercare Diagnostics, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: August 5, 1994. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: October 2026.

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