K243791 is an FDA 510(k) clearance for the Air Pressure Therapy System. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Xiamen Weiyou Intelligent Technology Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on January 13, 2025, 34 days after receiving the submission on December 10, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K243791 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2024 |
| Decision Date | January 13, 2025 |
| Days to Decision | 34 days |
| Submission Type | Special |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |