POWERPRESS UNIT
NEO MEDIC · Model P1000-NAR · UDI-DI 00860015634955
IRP
Prescription
10
510(k) clearances
38
Adverse events (1 deaths)
5
Recalls
101
Facilities
Description
Gradient Arterial Compression Inflation: 5 sec (+/- 0.5 sec), Foot 5 sec, Calf 2.5 sec Deflation: 15 sec (+/- 1 sec) Pressure: Adjustable from 40 mmHg to 120 mmHg Time setting: 0 - 60 min
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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