Cleared Traditional

K881388 - KIN-COM JR

K881388 is an FDA 510(k) clearance for KIN-COM JR, 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 17-day FDA review.

K881388 · Chattanooga Group, Inc. · Neurology device
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Apr 1988
Decision
17d
Days
Class 2
Risk

K881388 is an FDA 510(k) clearance for the KIN-COM JR. Classified as Dynamometer, Ac-powered (product code LBB), Class II - Special Controls.

Submitted by Chattanooga Group, Inc. (Red Bank, US). The FDA issued a Cleared decision on April 21, 1988 after a review of 17 days - a notably fast clearance 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: 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 Chattanooga Group, Inc. devices

FDA 510(k) Submission Details - K881388

510(k) Number K881388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1988
Decision Date April 21, 1988
Days to Decision 17 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
131d faster than avg
Panel avg: 148d · This submission: 17d
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.