K250244 is an FDA 510(k) clearance for the Compression Therapy Device (LGT-2210DS). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Guangzhou Longest Medical Technology Co., Ltd. (Guanzhou, CN). The FDA issued a Cleared decision on July 25, 2025, 179 days after receiving the submission on January 27, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K250244 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2025 |
| Decision Date | July 25, 2025 |
| Days to Decision | 179 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 |