Cleared Traditional

HYDROTRACK (K935509) - FDA 510(k) Clearance

Class I Physical Medicine device.

K935509 · Ferno Ille · Physical Medicine device
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Oct 1994
Decision
322d
Days
Class 1
Risk

K935509 is an FDA 510(k) clearance for the HYDROTRACK. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Ferno Ille (Wilmington, US). The FDA issued a Cleared decision on October 3, 1994 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - the FDA physical medicine 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Ferno Ille devices

Submission Details

510(k) Number K935509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1993
Decision Date October 03, 1994
Days to Decision 322 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 115d · This submission: 322d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXB Exerciser, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
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.