K242940 is an FDA 510(k) clearance for the Xrecovery (XR-001). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Shenzhen Xinrun Electric Appliances Co, Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 14, 2024, 50 days after receiving the submission on September 25, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K242940 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2024 |
| Decision Date | November 14, 2024 |
| Days to Decision | 50 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 |