Cleared Traditional

K802687 - SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS

K802687 is an FDA 510(k) clearance for SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS, manufactured by Intelligent Software Systems, Inc.. The device is a Class 2 Physical Medicine device with product code ILQ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K802687 · Intelligent Software Systems, Inc. · Physical Medicine device
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Feb 1981
Decision
98d
Days
Class 2
Risk

K802687 is an FDA 510(k) clearance for the SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS. Classified as System, Communication, Powered (product code ILQ), Class II - Special Controls.

Submitted by Intelligent Software Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1981 after a review of 98 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K802687

510(k) Number K802687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1980
Decision Date February 04, 1981
Days to Decision 98 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 116d · This submission: 98d
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.

K802687 · SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS
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