Cleared Traditional

K940223 - LEARN MODE WATERPROOF PENDANT PANIC BUTTON

K940223 is an FDA 510(k) clearance for LEARN MODE WATERPROOF PENDANT PANIC BUTTON, manufactured by Interactive Technologies, Inc.. The device is a Class 2 Physical Medicine device with product code IQA cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K940223 · Interactive Technologies, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
101d
Days
Class 2
Risk

K940223 is an FDA 510(k) clearance for the LEARN MODE WATERPROOF PENDANT PANIC BUTTON. Classified as System, Environmental Control, Powered (product code IQA), Class II - Special Controls.

Submitted by Interactive Technologies, Inc. (Washington, US). The FDA issued a Cleared decision on April 29, 1994 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3725 - 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 Interactive Technologies, Inc. devices

FDA 510(k) Submission Details - K940223

510(k) Number K940223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1994
Decision Date April 29, 1994
Days to Decision 101 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
14d faster than avg
Panel avg: 115d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IQA Device Classification - Class 2, Special Controls

Product Code IQA System, Environmental Control, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3725
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.