BWK

FDA Product Code BWK: Stimulator, Electro-acupuncture

Leading manufacturers include Wuxi Jiajian Medical Instrument Co., Ltd., Inno-Health Technology, Inc. and Biegler GmbH.

23
Total
23
Cleared
202d
Avg days
1979
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 88d recently vs 207d historically

FDA 510(k) Cleared Stimulator, Electro-acupuncture Devices (Product Code BWK)

23 devices
1–23 of 23
Cleared Mar 28, 2025
Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
K244030
Wuxi Jiajian Medical Instrument Co., Ltd.
Neurology · 88d
Cleared Mar 18, 2022
Needle Stimulator (Model: RJNS6-1)
K220153
Bozhou Rongjian Medical Appliance Co., Ltd.
Neurology · 58d
Cleared Aug 27, 2021
Needle Stimulator
K202861
Wuxi Jiajian Medical Instrument Co., Ltd.
Neurology · 333d
Cleared Feb 03, 2021
AXUS ES-5 Electro-Acupuncture Device
K200636
Lhasa Oms, Inc.
Neurology · 330d
Cleared Mar 09, 2017
ANSiStim-PP
K170391
Dyansys, Inc.
Neurology · 29d
Cleared May 26, 2016
Stivax
K152571
Biegler GmbH
Neurology · 260d
Cleared May 15, 2015
ANSISTIM
K141168
Dyansys, Inc.
Neurology · 374d
Cleared Nov 07, 2014
PANTHEON ELECTROSTIMULATOR
K133980
Pantheon Research
Neurology · 315d
Cleared Oct 02, 2014
Electro Auricular Device
K140530
Navigant Consulting, Inc.
Neurology · 212d
Cleared Jun 27, 2014
P-STIM
K140788
Biegler GmbH
Neurology · 88d
Cleared Aug 16, 2013
JIAJIAN CMN STIMULATOR
K130768
Wuxi Jiajian Medical Instrument Co., Ltd.
Neurology · 149d
Cleared Apr 11, 2013
JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS
K122812
Wuxi Jiajian Medical Instrument Co., Ltd.
Neurology · 210d
Cleared Aug 05, 2010
MULTI-PURPOSE HEALTH DEVICE
K093322
Upc Medical Supplies, Inc. Dba United Pacific Co.
Neurology · 286d
Cleared Apr 02, 2010
ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01
K091933
Inno-Health Technology, Inc.
Neurology · 276d
Cleared Dec 07, 2009
E-PULSE
K091875
Medevice Corporation
Neurology · 167d
Cleared Nov 24, 2008
MODEL ES-130
K081943
Ito Co., Ltd.
Neurology · 139d
Cleared Mar 30, 2006
P-STIM SYSTEM
K050123
Neuroscience Therapy Corp.
Neurology · 435d
Cleared Mar 28, 2006
ACULIFE, MODEL SMW-01
K051197
Inno-Health Technology, Inc.
Neurology · 322d
Cleared Jun 12, 2002
ACUSTIM
K014273
S.H.P. Intl. Pty., Ltd.
Neurology · 167d

About Product Code BWK - Regulatory Context

510(k) Submission Activity

23 total 510(k) submissions under product code BWK since 1979, with 23 receiving FDA clearance (average review time: 202 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - BWK Product Code

Recent submissions under BWK have taken an average of 88 days to reach a decision - down from 207 days historically, suggesting improved FDA processing for this classification.

BWK devices are reviewed by the Neurology panel. Browse all Neurology devices →