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PlasmaWave foot garment
Manamed, Inc. · Model M-21 · UDI-DI 00850998008331
JOW
Prescription
10
510(k) clearances
1,705
Adverse events (19 deaths)
32
Recalls
138
Facilities
Description
Universal compression foot garment, increases venous blood flow to help prevent deep vein thrombosis.
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) |
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Get your free API keyRead the docsData 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.