Cleared Traditional

K823511 - EMG BIOFEEDBACK DEVICE

K823511 is an FDA 510(k) clearance for EMG BIOFEEDBACK DEVICE, manufactured by Nemectron Medical, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K823511 · Nemectron Medical, Inc. · Neurology device
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Mar 1983
Decision
122d
Days
Class 2
Risk

K823511 is an FDA 510(k) clearance for the EMG BIOFEEDBACK DEVICE. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Nemectron Medical, Inc. (Walker, US). The FDA issued a Cleared decision on March 31, 1983 after a review of 122 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 Nemectron Medical, Inc. devices

FDA 510(k) Submission Details - K823511

510(k) Number K823511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1982
Decision Date March 31, 1983
Days to Decision 122 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 148d · This submission: 122d
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 K823511.
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
CALMSET 3 TM
K823146 · Thought Technology , Ltd. · Dec 1982
EMG 100T
K822814 · Thought Technology , Ltd. · Oct 1982
LIFE-TECH #1753 BIOFEEDBACK TRAINER
K812179 · Life-Tech Instruments, Inc. · Aug 1981