K162817 is an FDA 510(k) clearance for the Noddle(TM). This device is classified as a System, Communication, Powered (Class II - Special Controls, product code ILQ).
Submitted by Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. (Coralville, US). The FDA issued a Cleared decision on January 18, 2017, 104 days after receiving the submission on October 6, 2016.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3710.
| 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 |
| Product Code | ILQ — System, Communication, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3710 |