Cleared Traditional

K905576 - LINGRAPHICA VISUAL LANGUAGE PROSTHESIS

K905576 is an FDA 510(k) clearance for LINGRAPHICA VISUAL LANGUAGE PROSTHESIS, manufactured by Tolfa Corp.. The device is a Class 2 Physical Medicine device with product code ILQ cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K905576 · Tolfa Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
19d
Days
Class 2
Risk

K905576 is an FDA 510(k) clearance for the LINGRAPHICA VISUAL LANGUAGE PROSTHESIS. Classified as System, Communication, Powered (product code ILQ), Class II - Special Controls.

Submitted by Tolfa Corp. (Mountain View, US). The FDA issued a Cleared decision on December 31, 1990 after a review of 19 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 Tolfa Corp. devices

FDA 510(k) Submission Details - K905576

510(k) Number K905576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1990
Decision Date December 31, 1990
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
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.