Cleared Traditional

K971400 - MUSCLE RESPONSE MONITOR

K971400 is an FDA 510(k) clearance for MUSCLE RESPONSE MONITOR, manufactured by Enriching Your Life. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K971400 · Enriching Your Life · Neurology device
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Apr 1998
Decision
364d
Days
Class 2
Risk

K971400 is an FDA 510(k) clearance for the MUSCLE RESPONSE MONITOR. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Enriching Your Life (Granbury, US). The FDA issued a Cleared decision on April 14, 1998 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Enriching Your Life devices

FDA 510(k) Submission Details - K971400

510(k) Number K971400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1997
Decision Date April 14, 1998
Days to Decision 364 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
216d slower than avg
Panel avg: 148d · This submission: 364d
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 42
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K971400.
THE BAGNOLI-4 EMG SYSTEM
K981934 · Delsys, Inc. · Aug 1998
SLEEP MANAGEMENT SYSTEM
K981844 · Rmp, Inc. · Aug 1998
ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE
K980373 · Ultramind International , Ltd. · Apr 1998
PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE
K971708 · J & J Engineering, Inc. · Feb 1998
PATHWAY ELECTROMYOGRAPH
K973537 · The Prometheus Group · Dec 1997
BIO TROL
K972723 · Mindmedia Labs, Inc. · Oct 1997