K242615 is an FDA 510(k) clearance for the Intermittent pressure compression system (Compression Pump PT1005A. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Xiamen Taotao Technology Co., Ltd. (Xiamen City, CN). The FDA issued a Cleared decision on July 23, 2025, 323 days after receiving the submission on September 3, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K242615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2024 |
| Decision Date | July 23, 2025 |
| Days to Decision | 323 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 |