Cleared Traditional

K965006 - AT 62 EEG (A.K.A THE A

Also marketed or referenced as:
PHA-THETA TRAINER)

K965006 is an FDA 510(k) clearance for AT 62 EEG (A.K.A THE A, manufactured by Stoelting Co.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K965006 · Stoelting Co. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
51d
Days
Class 2
Risk

K965006 is an FDA 510(k) clearance for the AT 62 EEG (A.K.A THE A. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Stoelting Co. (Wood Dale, US). The FDA issued a Cleared decision on February 5, 1997 after a review of 51 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 Stoelting Co. devices

FDA 510(k) Submission Details - K965006

510(k) Number K965006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1996
Decision Date February 05, 1997
Days to Decision 51 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
97d faster than avg
Panel avg: 148d · This submission: 51d
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 K965006.
EMG RETRAINER
K972487 · Chattanooga Group, Inc. · Sep 1997
MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE
K970051 · Smith and Nephew Donjoy, Inc. · Jul 1997
MODEL ME 300 MUSCLE TESTER
K943535 · Regulatory Strategies, Inc. · Jun 1997
SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE
K954737 · J-Tech, Inc. · Jul 1996
AT53 DUAL CHANNEL EMG
K952797 · Stoelting Co. · Apr 1996
DIGITAL CONDUCTANCE METER
K924313 · The Jayms Co. · Mar 1996