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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nonthermal shortwave therapy device indicated for over the counter use for the treatment of pain
Regulation Description Shortwave diathermy.
Definition Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain.
Product CodePQY
Regulation Number 890.5290
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOELECTRONICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2025 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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