K223164 is an FDA 510(k) clearance for the Aquilo Sports CCT1500 System. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Aquilo Sports, LLC (Louisville, US). The FDA issued a Cleared decision on November 4, 2022, 28 days after receiving the submission on October 7, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K223164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2022 |
| Decision Date | November 04, 2022 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |