Cold Compression Wrap, Pro-Knee Wrap
Manamed, Inc. · Model CCW-PKW · UDI-DI 00810113683676
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
| 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 |
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 keyRead the docs