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510(k) K140530

Electro Auricular Device by Navigant Consulting, Inc. — Product Code BWK

K140530 is an FDA 510(k) premarket notification submitted by Navigant Consulting, Inc. for the device "Electro Auricular Device". The FDA issued a decision of Substantially Equivalent on October 2, 2014. The device falls under product code BWK (Stimulator, Electro-Acupuncture), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2014
Date Received
March 4, 2014
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 for product code BWK

  • K244030 — Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (March 28, 2025)
  • K220153 — Needle Stimulator (Model: RJNS6-1) (March 18, 2022)
  • K202861 — Needle Stimulator (August 27, 2021)
  • K200636 — AXUS ES-5 Electro-Acupuncture Device (February 3, 2021)
  • K170391 — ANSiStim-PP (March 9, 2017)
  • K152571 — Stivax (May 26, 2016)
  • K141168 — ANSISTIM (May 15, 2015)
  • K133980 — PANTHEON ELECTROSTIMULATOR (November 7, 2014)
  • K140788 — P-STIM (June 27, 2014)
  • K130768 — JIAJIAN CMN STIMULATOR (August 16, 2013)

FDA data resources