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510(k) K202861

Needle Stimulator by Wuxi Jiajian Medical Instrument Co., Ltd. — Product Code BWK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2021
Date Received
September 28, 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 Wuxi Jiajian Medical Instrument Co., Ltd.

  • K244030 — Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (March 28, 2025)
  • K231425 — Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) (March 27, 2024)
  • K222879 — Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (January 24, 2023)
  • K202893 — Transcutaneous Electrical Nerve Stimulator (June 18, 2021)
  • K192568 — Jiajian Self-Adhesive Electrode (February 3, 2021)
  • K123958 — JIAJIAN POINTOSELECT DIGITAL (October 28, 2013)
  • K130768 — JIAJIAN CMN STIMULATOR (August 16, 2013)
  • K122812 — JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS (April 11, 2013)
  • K112288 — JIAJIAN TENS (May 2, 2012)
  • K090199 — JIAJIAN ACUPUNCTURE NEEDLE (August 11, 2009)

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)
  • 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)
  • K140530 — Electro Auricular Device (October 2, 2014)
  • K140788 — P-STIM (June 27, 2014)
  • K130768 — JIAJIAN CMN STIMULATOR (August 16, 2013)