Cleared Traditional

FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403 (K914125) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K914125 · Ferno · Physical Medicine device
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Oct 1991
Decision
42d
Days
Class 2
Risk

K914125 is an FDA 510(k) clearance for the FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Ferno (Wilmington, US). The FDA issued a Cleared decision on October 25, 1991 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5100 - 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: 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 Ferno devices

Submission Details

510(k) Number K914125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1991
Decision Date October 25, 1991
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ILJ Bath, Hydro-massage
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5100
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 Physical Medicine devices follow this clearance model.