Cleared Traditional

K901290 - ELECTRO-GONIOMETER DIAGNOSTIC DEVICE

K901290 is an FDA 510(k) clearance for ELECTRO-GONIOMETER DIAGNOSTIC DEVICE, manufactured by Chattanooga Group, Inc.. The device is a Class 2 Neurology device with product code LBB cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K901290 · Chattanooga Group, Inc. · Neurology device
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Oct 1990
Decision
195d
Days
Class 2
Risk

K901290 is an FDA 510(k) clearance for the ELECTRO-GONIOMETER DIAGNOSTIC DEVICE. Classified as Dynamometer, Ac-powered (product code LBB), Class II - Special Controls.

Submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on October 1, 1990 after a review of 195 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1240 - 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 Chattanooga Group, Inc. devices

FDA 510(k) Submission Details - K901290

510(k) Number K901290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1990
Decision Date October 01, 1990
Days to Decision 195 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 148d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBB Device Classification - Class 2, Special Controls

Product Code LBB Dynamometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1240
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.