510(k) K251446
K251446 is an FDA 510(k) premarket notification submitted by Manamed, LLC for the device "PlasmaFlow X Compression Sleeve Device (XPF0001)". The FDA issued a decision of Substantially Equivalent on September 17, 2025. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Manamed, LLC has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2025
- Date Received
- May 9, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type