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PlasmaFlight

Manamed, Inc. · Model FLIGHT001 · UDI-DI 00850998008294

IRP

510(k) clearances

Adverse events (1 deaths)

Recalls

101

Facilities

Description

The PlasmaFlight is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.

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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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.