Home › Manamed, Inc. › PlasmaFlow Elite

PlasmaFlow Elite

Manamed, Inc. · Model PFE0001 · UDI-DI 00850998008010

JOW Prescription

510(k) clearances

1,711

Adverse events (19 deaths)

Recalls

138

Facilities

Description

The PlasmaFlow ELITE is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: Aid in the prevention of DVT Enhance blood circulation Diminish post-operative pain and swelling Reduce wound healing time Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.

Recalls

Date	Firm	Reason
2025-05-13	Cardinal Health 200, LLC	Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
2025-05-13	Cardinal Health 200, LLC	Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
2025-05-13	Cardinal Health 200, LLC	Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
2023-04-14	Stryker Sustainability Solutions	Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
2021-07-09	Ortho8, Inc.	EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
2021-07-09	Ortho8, Inc.	CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.