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510(k) Data Aggregation
K Number
K212935Device Name
Air Pressure Foot Massager
Manufacturer
Xiamen Simo Electronic Co., Ltd
Date Cleared
2022-02-19
(157 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
Xiamen Simo Electronic Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Air Pressure Foot Massager is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Device Description
Air Pressure Foot Massager has a pump. The pump is connected with the dedicated inflatable sleeve through the hose, one sleeve has 2 compression chambers. The pump compresses and inflates air into the chambers continuously to produce compression from the body tail end to body center and release the air after compression as one cycle process.
The device is equipped with a hand controller. In operation, the user simply turns the power on via the power button. The intensity (pressure) can be adjusted by purpose to avoid any discomfort. The device is powered by an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery. The materials of sleeve use medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance.
The Air Pressure Foot Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue by use of an inflatable sleeve. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.
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