{ "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": "2026-10-26", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "proprietary_name": [ "Disposable Comfort High, XL", "Dispo. Gait Trainer, L", "Basic High, Net, M", "Disposable High II, S", "Basic Basic, Net, L", "Sit-On Comfort High Hygi, L", "Sit-On Comfort High Hygi, M", "Active Micro Plus, XL", "Dispo. Micro Plus XXL, Box of 5 slings", "Gait Trainer, Bariatric", "Sit-On II, S", "Basic High, Net, L", "Basic High, Poly, Kid 10-14", "Standing Shell Vest, Kid 6-10", "Custom Amputee, XL", "Basic Low, Poly, M", "Gait Trainer, S", "Basic Basic, Poly, Kid 6-10", "Sit-On Comfort High, M", "Extension strap, 20 cm", "Disposable Twin Turner II, Regular", "Basic Hammock, XL", "Disposable High II, Kids 6-10", "Active Trainer, XL", "Sit-On High II, Kid 4-6", "Disposable Horizontal, Standard", "Basic Comfort High, Net, L", "Basic Low, Poly, XXL", "OR Sling, Poly, M", "Sit-On High, M", "Dispo. Gait Trainer, XL", "Basic High, Poly, S", "Disposable High II, L", "Basic Low, Net, S", "Basic Low, Poly, S", "Basic High, Poly, L", "Horizontal lifter, Foldable, 2 strap version", "Basic Comfort High, Net, S", "Basic Low, Net, L", "Active Trainer, Kid 6-10", "Sit-On Comfort High Hygi, XS", "Disposable High, Bariatric, XXL/XXXL", "Sit-On High II, M", "Active Micro Plus, L", "Basic Comfort High, Poly, L", "Horizontal lifter, Foldable, 1 strap version", "Basic Shell, XS", "Disposable Comfort High, M", "Standing Sling, S/M", "Basic Basic, Poly, XS", "Disposable High II, XL", "Basic Basic, Poly, Kid 10-14", "Basic High, Poly, Kid 4-6", "Active Micro, Poly, XXL", "Standing Sling, XXL", "Sit-On High, XS", "Sit-On II, XS", "Dispo. Micro Plus L, Box of 5 slings", "Sit-On High, Kid 6-10", "Basic High, Net, S", "Basic Basic, Poly, XXXL", "Repositioning Sling, TENCEL Box 10", "Disposable Leg Sling II", "Sit-On Comfort High, L", "Basic Basic, Net, Kid 6-10", "Sit-On High, XL", "Basic Shell, M", "Basic Comfort High, Net, M", "Sit-On Comfort High, XXL", "Basic Basic, Net, XS", "Disposable High, Kids 6-10", "Basic Basic, Net, S", "Sit-On Comfort High, XL", "Disposable High, XS", "Basic High Bariatric, 3XL", "Basic Low, Net, XXL", "Dispo. Micro Plus M, Box of 5 slings", "Cross hanger - 500kg", "Horizontal lifting support, stepped weight adjustment", "Lifting hanger MEDIUM", "Basic High, Poly, XXL", "Sit-On Comfort High, Kid 4-6", "Basic Low, Poly, XS", "Active Micro, Poly, L", "Basic Comfort High, Net, XXL", "OR Sling, Poly, L", "Basic Shell, S", "Horizontal lifting support, stepless weight adjustment", "Repositioning Sling, Grey net Box 10", "Basic Basic, Poly, M", "Disposable High II, XXL", "Basic Low, Net, XS", "Standing Sling, XL", "Sit-On Comfort, L", "Lifting hanger X-SMALL", "Basic High Bariatric, 4XL", "Active Trainer, XXL", "Sit-On Comfort, Kid 6-10", "Disposable High, Bariatric, XL/XXL", "Gait Trainer, XL", "Basic Low, Net, M", "Disposable Repo w. Smart Loops", "Sit-On High, L", "Standing Sling, L", "Sit-On High II, XL", "Twin Turner, Large", "Basic Comfort High, Net, XL", "Active Micro Plus, M", "Basic High Net, Kid 4-6", "Disposable Comfort High, L", "Basic Comfort High, Poly, S", "Sit-On, L", "Custom Amputee, M", "Basic High, Net, XL", "Repositioning Sling, Spacer", "Basic High, Net, Kid 10-14", "Pannus Support", "Active Trainer, Kid 10-14", "Sit-On Comfort High, XXXL", "Turner", "Disposable High II, M", "Disposable Comfort High, XXL", "Gait Trainer, L", "Sit-On High II, Kid 6-10", "Sit-On Comfort, S", "Sit-On, M", "Standing Shell Vest, Kid 10-16", "Sit-On High II, XXXL", "Basic Basic, Poly, XXL", "Active Micro Plus, Kid 10-14", "Basic Basic, Net, Kid 10-14", "Active Trainer, M", "Gait Trainer, M", "Basic Low, Poly, XL", "Basic Basic, Net, XXL", "Active Micro Plus, S", "Active Vest, Kid 10-16", "Active Micro Plus, Kids 4-6", "Sit-On Comfort High Hygi, S", "Active Micro, Poly, M", "Sit-On II, Kid 4-6", "Basic Basic, Net, M", "Disposable High, XL", "Modified Sling, Net", "Sit-On II, Kid 6-10", "Basic Basic, Poly, Kid 4-6", "Sit-On Comfort, M", "Dispo. Gait Trainer, S", "Repositioning Sling, Short, Box 10", "Multi Support Sling", "Disposable High, XXL", "Basic Hammock, L", "Disposable Twin Turner II, Large", "Custom Amputee, S", "Basic Basic, Poly, XL", "Basic Shell, L", "Dispo. Gait Trainer, M", "Disposable Comfort High, XS", "Basic Hammock, XS", "Sit-On, XL", "Sit-On II, XL", "Disposable High, S", "Dispo. Gait Trainer, XXL", "Custom Amputee, XS", "Active Vest, Kid 6-10", "Sit-On Comfort High Hygi, XL", "Basic Hammock, S", "Basic Comfort High, Poly, XS", "Active Vest, Kid 4-6", "Basic Shell, XL", "Sit-On Comfort, XS", "Active Micro Plus, Kid 6-10", "Sit-On Comfort High, XS", "Basic Low, Poly, L", "Sit-On Comfort High, Kid 6-10", "Basic High Bariatric, 5XL", "Active Micro Plus, XXL", "Basic High, Net, XXL", "Lifting hanger SMALL", "Positioning Sling, side", "Active Micro, Poly, S", "Sit-On, Kid 4-6", "Hip Support", "Basic Basic, Net, XL", "Repositioning Sling, Bariatric Box 5", "Basic Hammock, M", "Disposable Repo Sheet", "Horizontal Sling, Standard", "Sit-On II, L", "Gait Trainer, XXL", "Sit-On, XS", "Basic High, Poly, M", "Basic High, Poly, Kid 6-10", "Active Trainer, S", "Repositioning Sling, Poly", "Repositioning Sling, Spacer, 6 loops", "Disposable Multi Support Sling", "Sit-On, S", "Basic High, Poly, XS", "Sit-On High II, S", "Modified Sling, Poly", "Dispo. Micro Plus S, Box of 5 slings", "Active Trainer, L", "Basic Basic, Poly, L", "Dispo. Micro Plus XS, Box of 5 slings", "H-hanger", "Sit-On Comfort, Kid 4-6", "Custom Amputee, L", "Basic Comfort High, Poly, M", "Disposable High, Bariatric, L/XL", "Standing Shell Vest, XS", "Twin Turner, Regular", "Basic Basic, Poly, S", "Sit-On, Kid 6-10", "Extension strap, 30 cm", "Dispo. Micro Plus XL, Box of 5 slings", "Sit-On High II, L", "Basic High, Net, Kid 6-10", "Basic Comfort High, Poly, XL", "Cross hanger - 400kg", "Basic Basic, Net, Kid 4-6", "Sit-On Comfort High, S", "Sit-On Comfort, XL", "Active Trainer, XS", "Sit-On High, S", "Leg Sling Box of 10 pcs", "Active Micro Plus, XS", "Sit-On II, M", "Basic Low, Net, XL", "Connecting bar + cross hanger 500kg", "Disposable High II, XS", "Disposable Comfort High, S", "Twin Turner, Bariatric", "Basic Comfort High, Net, XS", "Basic High, Net, XS", "Basic High, Poly, XL", "Repositioning Sling Box 10", "Sit-On High II, XS", "Disposable High, M", "Disposable High, L" ], "establishment_type": [ "Manufacture Medical Device" ], "registration": { "registration_number": "3020157853", "fei_number": "3020157853", "status_code": "1", "initial_importer_flag": "N", "reg_expiry_date_year": "2026", "name": "GULDMANN-UKRAINE LTD", "address_line_1": "Shevchenko Str. 73", "address_line_2": "Kulykiv L'Viv Region", "city": "Lviv L'vivs'ka Oblast'", "state_code": "", "iso_country_code": "UA", "zip_code": "", "postal_code": "80362", "us_agent": { "name": "Mads Petersen", "business_name": "GULDMANN, INC.", "bus_phone_area_code": "813", "bus_phone_num": "2171624", "bus_phone_extn": "", "fax_area_code": "813", "fax_num": "8809558", "email_address": "mpe@guldmann.net", "address_line_1": "14401 McCormick Drive", "address_line_2": "Suite A", "city": "Tampa", "state_code": "FL", "iso_country_code": "US", "zip_code": "33626", "postal_code": "" }, "owner_operator": { "firm_name": "V. GULDMANN A/S", "owner_operator_number": "9027662", "official_correspondent": {}, "contact_address": { "address_1": "14401 McCormick Drive", "address_2": "Unit A", "city": "Tampa", "state_code": "FL", "state_province": "", "iso_country_code": "US", "postal_code": "33626" } } }, "pma_number": "", "k_number": "", "products": [ { "product_code": "ILE", "created_date": "2023-03-15", "owner_operator_number": "9027662", "exempt": "", "openfda": { "device_name": "Sling, Arm, Overhead Supported", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.3475", "device_class": "1" } } ] } ] }