FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PlasmaFlow X Compression Sleeve Device (XPF0001)
K Number: K251446
·
Decision Sep 17, 2025
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
1
Review Days
131
Basic Information
- Device Name
- PlasmaFlow X Compression Sleeve Device (XPF0001)
- K Number
- K251446
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Manamed, LLC
- Date Received
- May 9, 2025
- Decision Date
- September 17, 2025
- Product Code
- JOW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOW), ordered by most recent decision date.
Compression Therapy Device (LGT-2202DVT)
FDA 510(k)
FDA Class 2
·Cardiovascular
NanoPress 760A-BT (760A-BT)
FDA 510(k)
FDA Class 2
·Cardiovascular
Bio Arterial Deluxe (IC-BAP-DX)
FDA 510(k)
FDA Class 2
·Cardiovascular
Sequential Compression System (SCD600)
FDA 510(k)
FDA Class 2
·Cardiovascular
VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr
FDA 510(k)
FDA Class 2
·Cardiovascular
PnueAira (PNCU-01)
FDA 510(k)
FDA Class 2
·Cardiovascular