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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


Premarket Reviews
ManufacturerDecision
NATURES PILLOWS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2022 1 1

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 1 1
Insufficient Information 1 1

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