Cleared Traditional

K162817 - Noddle(TM)

K162817 is an FDA 510(k) clearance for Noddle(TM), manufactured by Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.. The device is a Class 2 Physical Medicine device with product code ILQ cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K162817 · Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
104d
Days
Class 2
Risk

K162817 is an FDA 510(k) clearance for the Noddle(TM). Classified as System, Communication, Powered (product code ILQ), Class II - Special Controls.

Submitted by Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. (Coralville, US). The FDA issued a Cleared decision on January 18, 2017 after a review of 104 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 - K162817

510(k) Number K162817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2016
Decision Date January 18, 2017
Days to Decision 104 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
12d faster than avg
Panel avg: 116d · This submission: 104d
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.

Regulatory Peers - ILQ System, Communication, Powered

All 28
Devices cleared under the same product code (ILQ) and FDA review panel - the closest regulatory comparables to K162817.
P.A.T. SYSTEM
K943035 · Mathews Assoc., Inc. · Oct 1994
COMFORT KEYBOARD SYSTEM
K930044 · Health Care Keyboard Co., Inc. · Jul 1994
LIGHTWRITER
K931855 · Zygo Corp. · May 1994
R & D BATTERIES, INC. PART NUMBER 5113
K935244 · R & D Batteries, Inc. · Apr 1994
MLT-2
K935981 · Med Labs, Inc. · Feb 1994
LIBERATOR
K925387 · Prentke Romich Co. · Mar 1993
K162817 · Noddle(TM)
Download PDF FDA Summary Iowa Adaptive Technol…