{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "158850", "product_res_number": "Z-0205-2018", "event_date_initiated": "2017-01-13", "event_date_created": "2017-12-06", "recall_status": "Terminated", "event_date_terminated": "2023-05-24", "res_event_number": "78182", "product_code": "IRP", "k_numbers": [ "K120166" ], "product_description": "Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses)\n\nProduct Usage:\nIntended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.", "code_info": "none", "firm_fei_number": "3005515255", "recalling_firm": "Won Industry Co.", "address_1": "7-12 Bangadari-Gil Siheung-si Korea the Republic of", "reason_for_recall": "Distribution of unapproved devices with incorrect air compression level setup", "root_cause_description": "Nonconforming Material/Component", "action": "Beginning on January 13, 2017, Won Industry Co., Ltd. distributed a Recall Request notices to their customers via email advising customers to retrieve the devices subject to recall.", "product_quantity": "3", "distribution_pattern": "Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico", "openfda": { "k_number": [ "K253919", "K253150", "K102319", "K193550", "K122112", "K140519", "K213000", "K202395", "K213533", "K202044", "K253076", "K240122", "K113275", "K220217", "K222206", 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