Cleared Traditional

K890596 - MED-A-CALL ASSIST DEVICE (FDA 510(k) Clearance)

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

K890596 · Silent Call Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
46d
Days
Class 2
Risk

K890596 is an FDA 510(k) clearance for the MED-A-CALL ASSIST DEVICE. Classified as System, Environmental Control, Powered (product code IQA), Class II - Special Controls.

Submitted by Silent Call Corp. (Clarkston, US). The FDA issued a Cleared decision on March 14, 1989 after a review of 46 days - a notably fast clearance cycle.

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: 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 Silent Call Corp. devices

Submission Details

510(k) Number K890596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1989
Decision Date March 14, 1989
Days to Decision 46 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
69d faster than avg
Panel avg: 115d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.