Device Recall Apollo Therapy Laser

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to states of: AZ, AR, CA, GA, IL, IN, IA, KS, MI, MN, MO, NY, OH, OR, PA, UT and WA.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Pivotal Health Solutions, 724 Oakwood Road, Watertown SD 57201-4133
  • 제조사 모회사 (2017)
  • Source
    USFDA