Cleared Traditional

K945257 - 577ES (ERGOSENSE)

K945257 is an FDA 510(k) clearance for 577ES (ERGOSENSE), manufactured by Lumex, Inc.. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K945257 · Lumex, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
180d
Days
Class 2
Risk

K945257 is an FDA 510(k) clearance for the 577ES (ERGOSENSE). Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Lumex, Inc. (Bay Shore, US). The FDA issued a Cleared decision on April 26, 1995 after a review of 180 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Lumex, Inc. devices

FDA 510(k) Submission Details - K945257

510(k) Number K945257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1994
Decision Date April 26, 1995
Days to Decision 180 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 115d · This submission: 180d
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 17
Devices cleared under the same product code (INO) and FDA review panel - the closest regulatory comparables to K945257.
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K864366 · Invacare Corp. · Dec 1986