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#4 Adult Boot XL (4 cells)
MEGO afek Agricultural Cooperative Society Ltd · Model 4 Boot XL · UDI-DI 07290105872685
JOW
Prescription
1
510(k) clearances
1,711
Adverse events (19 deaths)
32
Recalls
139
Facilities
Description
The #4 Adult Boot XL (4 cells) compression garment fastened around the area to be treated. The garment contains overlapping air chambers. These air chambers are filled with air from the console in sequence, applying a compressive massage. Once the entire area has been compressed, the console releases the pressure, and there is a brief pause. Then the process starts over again, and is repeated until the treatment session is complete.
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.