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Ballancer Gold (US)

MEGO afek Agricultural Cooperative Society Ltd · Model 1212 · UDI-DI 07290105879165

IRP

510(k) clearances

Adverse events (1 deaths)

Recalls

101

Facilities

Description

Ballancer® Gold is a massage system intended for use by people in good health. As noted above, Ballancer® Gold simulates the kneading and stroking action of manual massage by use of an inflatable garment that fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion.

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.