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4 chamber sleeve
DAESUNG MAREF CO.,LTD. · Model 4CHSET · UDI-DI 08809802640368
IRP
Prescription
3
510(k) clearances
38
Adverse events (1 deaths)
5
Recalls
100
Facilities
Description
LEG SLEEVE Large 2ea, LEG SLEEVE XLarge 2ea, LEG SLEEVE XXLarge 2ea, ARM SLEEVE 1ea, WAIST SLEEVE 1ea, CENTER BODY SLEEVE 1ea, CENTER BODY EXTENSION ZIPPER 2ea [One Set Box]
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-17 | Zhejiang Luyao Electronics Technology Co., Ltd. | Regulatory documentation error and misleading color packaging claim. |
| 2023-03-07 | Compass Health Brands (Corporate Office) | Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indica |
| 2017-01-13 | Won Industry Co. | Distribution of unapproved devices with incorrect air compression level setup |
| 2017-01-13 | Won Industry Co. | Distribution of unapproved devices with incorrect air compression level setup |
| 2011-08-23 | CoolSystems, Inc. | It was discovered that some Game Ready Professional Therapy System units that were to have been quarantined pending final inspection and testing were inadvertently moved to finishe |
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