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510(k) K051197

ACULIFE, MODEL SMW-01 by Inno-Health Technology, Inc. — Product Code BWK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2006
Date Received
May 10, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electro-Acupuncture
Device Class
Class U
Regulation Number
Review Panel
NE
Submission Type

Other clearances by Inno-Health Technology, Inc.

  • K091933 — ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 (April 2, 2010)

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