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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthosis, limb, for back pain
Regulation Description Limb orthosis.
Definition Intended to provide pressure to the soleus muscle for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities.
Product CodePMV
Regulation Number 890.3475
Device Class 1

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