Device Recall AxioBionics Wearable Therapy FreeStep Sleeve

  • Modelo / Serial
    Catalog numbers for the FreeStep Sleeves include 10000 and 10001 with Serial numbers 1436 and 1458. Catalog numbers for the BioGel Velcro Electrodes include118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, and 130.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution--USA (nationwide) including the states of AZ, GA, IL, IN, MI, MO, NY, TX, and WY.
  • Descripción del producto
    AxioBionics Wearable TherapyFreeStep Sleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". || Cutaneous electrode garments for neuromuscular electrical stimulation.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Axiobionics, LLC, 6111 Jackson Rd, Ann Arbor MI 48103-9167
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA