Cleared Traditional

COMFORT KEYBOARD SYSTEM (K930044) - FDA 510(k) Clearance

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

K930044 · Health Care Keyboard Co., Inc. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Jul 1994
Decision
555d
Days
Class 2
Risk

K930044 is an FDA 510(k) clearance for the COMFORT KEYBOARD SYSTEM. Classified as System, Communication, Powered (product code ILQ), Class II - Special Controls.

Submitted by Health Care Keyboard Co., Inc. (Menomonee Falls, US). The FDA issued a Cleared decision on July 14, 1994 after a review of 555 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Health Care Keyboard Co., Inc. devices

Submission Details

510(k) Number K930044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1993
Decision Date July 14, 1994
Days to Decision 555 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
440d slower than avg
Panel avg: 115d · This submission: 555d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.