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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
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

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1

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