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510(k) K133980

PANTHEON ELECTROSTIMULATOR by Pantheon Research — Product Code BWK

K133980 is an FDA 510(k) premarket notification submitted by Pantheon Research for the device "PANTHEON ELECTROSTIMULATOR". The FDA issued a decision of Substantially Equivalent on November 7, 2014. The device falls under product code BWK (Stimulator, Electro-Acupuncture), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2014
Date Received
December 27, 2013
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)
  • K140530 — Electro Auricular Device (October 2, 2014)
  • K140788 — P-STIM (June 27, 2014)
  • K130768 — JIAJIAN CMN STIMULATOR (August 16, 2013)

FDA data resources