FDA Product Code BWK: Stimulator, Electro-acupuncture
Leading manufacturers include Wuxi Jiajian Medical Instrument Co., Ltd., Lhasa Oms, Inc. and Bozhou Rongjian Medical Appliance Co., Ltd..
FDA 510(k) Cleared Stimulator, Electro-acupuncture Devices (Product Code BWK)
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 Review Time
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 →