FDA 510(k) Application Details - K020020

Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief

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510(K) Number K020020
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant WELL-LIFE HEALTHCARE, INC.
NO. 5 ALLEY 5 LANE CHENG HSING
CHUNG CHING RD., PEI TUN DIST.
TAICHUNG TW
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Contact TONY C CHANG
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 01/03/2002
Decision Date 12/30/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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