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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, electro-acupuncture
510(k) Number K091933
Device Name ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01
Applicant
INNO-HEALTH TECHNOLOGY, INC.
8F-2, NO. 61 KUNG-YI ROAD
SECTION 2
TAICHUNG,  TW 408
Applicant Contact TERRY C CHANG
Correspondent
INNO-HEALTH TECHNOLOGY, INC.
8F-2, NO. 61 KUNG-YI ROAD
SECTION 2
TAICHUNG,  TW 408
Correspondent Contact TERRY C CHANG
Classification Product Code
BWK  
Date Received06/30/2009
Decision Date 04/02/2010
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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