510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162817Substantially Equivalent

Noddle(TM)

Iowa Adaptive Technologies, Inc. dba Voxello, Inc., Coralville IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162817 is the FDA 510(k) clearance record for Noddle(TM), a class II device, cleared for Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. on under FDA product code ILQ (System, Communication, Powered). FDA records list one 510(k) clearance for Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. As of , FDA records show no recalls naming K162817.

Clearance record

Decision date
Received
(104 days to decision)
Product code
ILQ System, Communication, Powered
Regulation
21 CFR 890.3710
Device class
Class II
Review panel
Physical Medicine
Applicant
Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. 2500 Crosspark Rd., Coralville IA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ILQ

Trailing 12 months

FDA records hold no clearances under product code ILQ in the trailing twelve months.

FDA records show no clearances under product code ILQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ILQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260