510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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BWKUnclassified

Stimulator, Electro-Acupuncture

Unknown
FDA source (opens on fda.gov)

BWK is the FDA product code for Stimulator, Electro-Acupuncture. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BWK
Device name
Stimulator, Electro-Acupuncture
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
23
Ingested recalls
0

Clearances, product code BWK

By decision year
23 clearances under product code BWK with a decision year between 1979 and 2025, 1984 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code BWK by decision year
YearClearances
19791
19843
20021
20062
20081
20091
20102
20132
20143
20151
20161
20171
20212
20221
20251

Applicants with the most clearances

Product code BWK
Applicants holding the most 510(k) clearances under product code BWK
ApplicantClearances
Wuxi Jiajian Medical Instrument Co., Ltd4
Biegler GmbH2
Dyansys, Inc.2
Inno-Health Technology Co., Ltd.2
Anritsu America Co.1
Bio-Stimu Trend Corp.1
Bozhou Rongjian Medical Appliance Co., Ltd.1
Ito Co., Ltd.1
Lhasa Oms, Inc.1
Lu LU Enterprise Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order