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510(k) K141168

ANSISTIM by Dyansys, Inc. — Product Code BWK

K141168 is an FDA 510(k) premarket notification submitted by Dyansys, Inc. for the device "ANSISTIM". The FDA issued a decision of Substantially Equivalent on May 15, 2015. The device falls under product code BWK (Stimulator, Electro-Acupuncture), a Class U device. Dyansys, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2015
Date Received
May 6, 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 by Dyansys, Inc.

  • K221425 — Primary Relief (September 13, 2022)
  • K221231 — Drug Relief v1 (June 6, 2022)
  • K220397 — ANSiStim-PP (May 12, 2022)
  • K213188 — Primary Relief (January 31, 2022)
  • K212859 — First Relief (December 20, 2021)
  • K211971 — Drug Relief v1 (November 5, 2021)
  • K202940 — First Relief v1 (December 29, 2020)
  • K173861 — Drug Relief (May 2, 2018)
  • K170391 — ANSiStim-PP (March 9, 2017)
  • K091397 — ECSCOPE 200 (July 8, 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)
  • 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)
  • 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)

FDA data resources