{
  "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": "2026-09-07",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "proprietary_name": [
        "Prosthetic gloves for women",
        "MySkin Move",
        "Myo prosthetic Skin Natural gloves for women",
        "Triton Footshell",
        "Sticky Spot, Brim Pad Sticky Cover",
        "Compression Liner Cushion",
        "Prosthetic Skin Natural gloves for adolescents",
        "Myo prosthetic gloves for women",
        "Foot Cosmetics",
        "Prosthetic Sock - Plain Knit",
        "Kenevo Protective Cover",
        "Custom Sleeve",
        "michelangelo glove for men",
        "bebionic Silicone Glove",
        "C-Leg Protective Cover w/o shield",
        "Functional stocking",
        "Foam Cover",
        "Myo prosthetic Skin Natural gloves for children",
        "Myo prosthetic gloves for adolescents and men",
        "Foam Cover, AK",
        "Uneo Unique Custom Liner",
        "Cosmetic foam cover for hip ex.",
        "Uneo",
        "Prosthetic Skin Natural gloves for women",
        "Functional Cosmesis C-Leg",
        "Genium X4 Protective cover, short",
        "MySkin Myo",
        "Prosthetic Sock dis. Cotton-prox. Terry",
        "C-Leg Protector",
        "Harmony Sleeve",
        "Physio inner hands for women",
        "Compression Shrinker for transtib.amp.CCL1",
        "C-Leg Guard",
        "Skeo Sealing TT",
        "Myo prosthetic gloves for children",
        "Skeo Sealing",
        "Liner Dynamic Vacuum System",
        "michelangelo glove translucent / black",
        "Soft Touch",
        "Functional cosmesis Genium X4",
        "Connection Plate",
        "Myo prosthetic Skin Natural gloves for adolescents and women",
        "AeroLink Hybrid Liner",
        "Caleo 3D",
        "Prosthetic gloves for adolescents and men",
        "Myo prosthetic Skin Natural gloves for men",
        "Pre-Shaped, Cored, Flexed AK Cover",
        "Uneo Flex Liner",
        "AxonSkin Silicone Glove",
        "Skeo 3D",
        "Thigh kit/Magnetic closure",
        "michelangelo glove for women",
        "Skeo Sealing 3D",
        "Functional Stocking",
        "Physio inner hands for children",
        "Prosth. Sock, Terry Cloth",
        "Shield insert",
        "Skeo Unique",
        "Footshell 1C30",
        "Silicon Gel Liner",
        "AK Prosthetic Shrinker",
        "Uneo, Uneo Skinguard",
        "Skeo",
        "Prosthetic gloves for children",
        "Functional Cosmesis C-Leg (Knee Part)",
        "Genium X4 Protective cover, long",
        "Bebionic skin silicone black",
        "AK Adapt Liner",
        "iconiq",
        "Prosthetic Skin Natural gloves for children",
        "Functional Cosmesis Genium",
        "mHand Skin",
        "Special Pros.Sock for Liner, Terry Cloth",
        "Cosmetic foam cover",
        "Myo prosthetic gloves for adolescents and women",
        "Derma Seal Trans Ped",
        "Foam Cover, Tibial-square",
        "Caleo",
        "Cosmetic Foam Cover",
        "Uneo 3D, Fresh",
        "SKEO 3D TT",
        "Functional knee part",
        "BK Prosthetic Shrinker",
        "Uneo Skinguard",
        "Skeo Pure",
        "Prosthetic Sock, BK, Wool",
        "Foam Cover, pediatric BK, TT",
        "SKEO 3D",
        "Prosthetic Sock dis. Terry-prox. Cotton",
        "Genium X3 Protective Cover",
        "Harmony Taper Sleeve",
        "Physio inner hands for men",
        "Compression Shrinker for transfem.amp.CCL1",
        "Functional Cosmesis Genium (Knee Part)",
        "Skeo up Daily Assist",
        "Liner fit kit",
        "Compression Liner Locking",
        "Special Prosth. Sock for Ob Liner, Nylon",
        "Gaitor Sleeve",
        "Skeo Skinguard",
        "Bebionic skin silicone",
        "Derma Seal Double forte",
        "ProSeal SIL Liner",
        "Skeo Unique Liner"
      ],
      "establishment_type": [
        "Develop Specifications But Do Not Manufacture At This Facility",
        "Export Device to the United States But Perform No Other Operation on Device",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "9616494",
        "fei_number": "3003117657",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH",
        "address_line_1": "Max-Naeder-Strasse 15",
        "address_line_2": "",
        "city": "DUDERSTADT Lower Saxony",
        "state_code": "",
        "iso_country_code": "DE",
        "zip_code": "",
        "postal_code": "D-37115",
        "us_agent": {
          "name": "Caleb Beck",
          "business_name": "Otto Bock HealthCare LP",
          "bus_phone_area_code": "801",
          "bus_phone_num": "9746647",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "Caleb.Beck@ottobock.com",
          "address_line_1": "3820 West Great Lakes Drive",
          "address_line_2": "",
          "city": "Salt Lake City",
          "state_code": "UT",
          "iso_country_code": "US",
          "zip_code": "84120",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Ottobock SE & Co. KGaA",
          "owner_operator_number": "8010097",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "Max-Naeder-Strasse  15",
            "address_2": "",
            "city": "Duderstadt",
            "state_code": "DE-NI",
            "state_province": "Lower Saxony",
            "iso_country_code": "DE",
            "postal_code": "37115"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "IPM",
          "created_date": "2014-08-04",
          "owner_operator_number": "8010097",
          "exempt": "",
          "openfda": {
            "device_name": "Cover, Limb",
            "medical_specialty_description": "Physical Medicine",
            "regulation_number": "890.3025",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}