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510(k) K200636

AXUS ES-5 Electro-Acupuncture Device by Lhasa Oms, Inc. — Product Code BWK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2021
Date Received
March 10, 2020
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 Lhasa Oms, Inc.

  • K062003 — NEURO WAVE 6 (September 19, 2007)
  • K060517 — POINTER EXCEL (June 19, 2006)
  • K060508 — POINTER PLUS (June 19, 2006)
  • K061080 — IR PRO 250 (June 14, 2006)
  • K050989 — AWQ-104 (April 6, 2006)
  • K051020 — ES-160 (February 24, 2006)
  • K050435 — E-STIM II (September 6, 2005)

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)
  • K170391 — ANSiStim-PP (March 9, 2017)
  • K152571 — Stivax (May 26, 2016)
  • K141168 — ANSISTIM (May 15, 2015)
  • K133980 — PANTHEON ELECTROSTIMULATOR (November 7, 2014)
  • K140530 — Electro Auricular Device (October 2, 2014)
  • K140788 — P-STIM (June 27, 2014)
  • K130768 — JIAJIAN CMN STIMULATOR (August 16, 2013)