Cleared Traditional

K904796 - MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T

K904796 is an FDA 510(k) clearance for MEDICAL ALERT SYSTEM, manufactured by Personal Emergency Response System. The device is a Class 2 Physical Medicine device with product code ILQ cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K904796 · Personal Emergency Response System · Physical Medicine device
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Nov 1990
Decision
34d
Days
Class 2
Risk

K904796 is an FDA 510(k) clearance for the MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T. Classified as System, Communication, Powered (product code ILQ), Class II - Special Controls.

Submitted by Personal Emergency Response System (East Longmeadow, US). The FDA issued a Cleared decision on November 26, 1990 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3710 - 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 Personal Emergency Response System devices

FDA 510(k) Submission Details - K904796

510(k) Number K904796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1990
Decision Date November 26, 1990
Days to Decision 34 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILQ Device Classification - Class 2, Special Controls

Product Code ILQ System, Communication, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3710
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.