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510(k) K152571

Stivax by Biegler GmbH — Product Code BWK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2016
Date Received
September 9, 2015
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 Biegler GmbH

  • K140788 — P-STIM (June 27, 2014)
  • K121198 — BW685, BW685S (July 12, 2012)

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  • K170391 — ANSiStim-PP (March 9, 2017)
  • K141168 — ANSISTIM (May 15, 2015)
  • K133980 — PANTHEON ELECTROSTIMULATOR (November 7, 2014)
  • K140530 — Electro Auricular Device (October 2, 2014)
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  • K130768 — JIAJIAN CMN STIMULATOR (August 16, 2013)