Cleared Traditional

BACK-ON-TRAC, MODEL 101BOT (K984190) - FDA 510(k) Clearance

Class I Neurology device.

K984190 · Back-On-Track, Inc. · Neurology device
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Mar 1999
Decision
112d
Days
Class 1
Risk

K984190 is an FDA 510(k) clearance for the BACK-ON-TRAC, MODEL 101BOT. Classified as Apparatus, Traction, Non-powered (product code HST), Class I - General Controls.

Submitted by Back-On-Track, Inc. (St. Charles, US). The FDA issued a Cleared decision on March 15, 1999 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.5850 - 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 Back-On-Track, Inc. devices

Submission Details

510(k) Number K984190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1998
Decision Date March 15, 1999
Days to Decision 112 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 148d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HST Apparatus, Traction, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.