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510(k) Data Aggregation
K Number
K191441Device Name
Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)
Manufacturer
Date Cleared
2021-03-05
(645 days)
Product Code
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
Maxstar Industrial Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Air Relax/ Compressible Limb Sleeve System (Model: AR-1.0) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Relax/ Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) simulates kneading and stroking of tissues by using an inflatable garment.
Device Description
AR-1.0, AR-2.0is combined with leg, foot, garments. Leg garment has four air chambers operated by STEP3 controller and foot has one air chamber operated by STEP1. STEP3 controls a leg garment compressing sequentially in order of foot, calf and thigh and then injecting fresh air inside a leg garment through holes of garment to prevent from generating sweat by long wear of a garment.
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