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510(k) K170391

ANSiStim-PP by Dyansys, Inc. — Product Code BWK

K170391 is an FDA 510(k) premarket notification submitted by Dyansys, Inc. for the device "ANSiStim-PP". The FDA issued a decision of Substantially Equivalent on March 9, 2017. 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
March 9, 2017
Date Received
February 8, 2017
Clearance Type
Special
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)
  • K141168 — ANSISTIM (May 15, 2015)
  • 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)
  • 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)

FDA data resources