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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, electrical, transcutaneous, for arthritis
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Definition Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).
Product CodeNYN
Regulation Number 882.5890
Device Class 2


Premarket Reviews
ManufacturerDecision
RUDOLF STORZ GMBH
  SUBSTANTIALLY EQUIVALENT 1
VISION QUEST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

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