K241256 is an FDA 510(k) clearance for the JetBoots PRO Plus. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Therabody, Inc. (Los Angeles, US). The FDA issued a Cleared decision on August 30, 2024, 116 days after receiving the submission on May 6, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K241256 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2024 |
| Decision Date | August 30, 2024 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |