Manamed, LLC · Class II · Cleared Sep 17, 2025
| K-number | K251446 |
| Device name | PlasmaFlow X Compression Sleeve Device (XPF0001) |
| Applicant | Manamed, LLC |
| Product code | JOW |
| Device class | Class II |
| Decision date | Sep 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.5800 |
The PlasmaFlow X Compression Sleeve Device (XPF0001) is a portable, physician-prescribed system for home or clinical use that prevents deep vein thrombosis (DVT) by stimulating blood flow in the extremities through muscle contraction simulation. It is also indicated to enhance circulation, reduce post-operative pain and swelling, accelerate wound healing, and treat various venous and diabetic ulcers and edema in the lower limbs.
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View the full FDA submission: accessdata.fda.gov