The following data is part of a premarket notification filed by Aquilo Sports Llc with the FDA for Aquilo Sports Cct1500 System.
| Device ID | K223164 |
| 510k Number | K223164 |
| Device Name: | Aquilo Sports CCT1500 System |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Aquilo SPorts LLC 1902 Campus Pl Ste 12 Louisville, KY 40299 |
| Contact | JP Spence |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-10-07 |
| Decision Date | 2022-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850009827333 | K223164 | 000 |