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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthosis, truncal, for dysmenorrhea
Regulation Description Truncal orthosis.
Definition A truncal orthosis for dysmenorrhea is a device intended to provide pressure to acupressure points on the lower abdomen and lower back for the purpose of reducing menstrual pain symptoms including cramps, abdominal pain and backache.
Product CodeNJB
Regulation Number 890.3490
Device Class 1