Device Recall Apollo Therapy Laser

  • Modèle / numéro de série
    DT-1102, 1105, 1106, 1109, 1110, 1112,1114, 1115, 1116, 1118,1119, 1120, 1121, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1134, 1135, 1136, 1137, 1138, 1139, 1302, 1303, 1304, 1309.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: AZ, AR, CA, GA, IL, IN, IA, KS, MI, MN, MO, NY, OH, OR, PA, UT and WA.
  • Description du dispositif
    Apollo (cold) Laser Desktop Control Units, Model AP2-DT. || The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and / or promoting relaxation of muscle.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Pivotal Health Solutions, 724 Oakwood Road, Watertown SD 57201-4133
  • Société-mère du fabricant (2017)
  • Source
    USFDA