Cleared Special

ANSiStim-PP

K170391 · Dyansys, Inc. · Neurology
Mar 2017
Decision
29d
Days
—
Risk

About This 510(k) Submission

K170391 is an FDA 510(k) clearance for the ANSiStim-PP, a Stimulator, Electro-acupuncture, submitted by Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on March 9, 2017, 29 days after receiving the submission on February 8, 2017. This device falls under the Neurology review panel.

Submission Details

510(k) Number K170391 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2017
Decision Date March 09, 2017
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code BWK — Stimulator, Electro-acupuncture
Device Class —

Similar Devices — BWK Stimulator, Electro-acupuncture

All 22
Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
K244030 · Wuxi Jiajian Medical Instrument Co., Ltd. · Mar 2025
Needle Stimulator (Model: RJNS6-1)
K220153 · Bozhou Rongjian Medical Appliance Co., Ltd. · Mar 2022
Needle Stimulator
K202861 · Wuxi Jiajian Medical Instrument Co., Ltd. · Aug 2021
AXUS ES-5 Electro-Acupuncture Device
K200636 · Lhasa Oms, Inc. · Feb 2021
Stivax
K152571 · Biegler GmbH · May 2016
ANSISTIM
K141168 · Dyansys, Inc. · May 2015