Cleared Traditional

K031045 - AEROLET TOILET LIFT, MODEL AER-01

K031045 is an FDA 510(k) clearance for AEROLET TOILET LIFT, manufactured by Economic Holland B.V.. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K031045 · Economic Holland B.V. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
71d
Days
Class 2
Risk

K031045 is an FDA 510(k) clearance for the AEROLET TOILET LIFT, MODEL AER-01. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Economic Holland B.V. (Clemmons, US). The FDA issued a Cleared decision on July 10, 2003 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3110 - 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.

FDA 510(k) Submission Details - K031045

510(k) Number K031045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2003
Decision Date July 10, 2003
Days to Decision 71 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 116d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INO Device Classification - Class 2, Special Controls

Product Code INO Chair, Positioning, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3110
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.

Regulatory Peers - INO Chair, Positioning, Electric

All 51
Devices cleared under the same product code (INO) and FDA review panel - the closest regulatory comparables to K031045.
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K002318 · United Chair Mfg., LLC · Oct 2000
K031045 · AEROLET TOILET LIFT, MODEL AER-01
Download PDF FDA Summary Economic Holland B.V.