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510(k) Data Aggregation
K Number
K201730Device Name
Powered Inflatable Tube Massager - SLIM UP DRAIN
Manufacturer
Date Cleared
2022-08-22
(789 days)
Product Code
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
Foggiare Technologies LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IAF-SYSTEM is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health. IAF-SYSTEM simulates kneading of tissues by using an inflatable garment.
Device Description
Subject device consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has four (4) compression chambers. The compression massage direction is from limb end to body center. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body
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