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Cold Compression Wrap, Pro-Knee Wrap

Manamed, Inc. · Model CCW-PKW · UDI-DI 00810113683676

IRPIME
10
510(k) clearances
38
Adverse events (1 deaths)
5
Recalls
101
Facilities

Description

Pneumatic compression pump that attaches to one of our six compression wraps for elbow, hip, knee, shoulder, back, and ankle. Pump comes with a battery, screwdriver to insert the battery, and a charger. The compression wrap attachments are sold separately and have one removable cryo-gel pack. Features: -2 pneumatic ports to treat 1 or 2 areas at one time -Adjustable pressure settings: 20, 40, 60, 80, or 100 mmHg to control edema -LCD screen displays pressure to show inflation cycle -Set treatment times - 10-minute intervals up to 120 minutes with default of 30 minutes -Has a rechargeable battery for portability or use while charging -Easy-to-clean nylon material -Simple strapping system for donning & doffing

Recalls

DateFirmReason
2025-01-17Zhejiang Luyao Electronics Technology Co., Ltd.Regulatory documentation error and misleading color packaging claim.
2023-03-07Compass 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
2017-01-13Won Industry Co.Distribution of unapproved devices with incorrect air compression level setup
2017-01-13Won Industry Co.Distribution of unapproved devices with incorrect air compression level setup
2011-08-23CoolSystems, 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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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.