Cleared Traditional

Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)

K244030 · Wuxi Jiajian Medical Instrument Co., Ltd. · Neurology
Mar 2025
Decision
88d
Days
—
Risk

About This 510(k) Submission

K244030 is an FDA 510(k) clearance for the Needle Stimulator (CMNS6-1 PLUS, CMNS6-3), a Stimulator, Electro-acupuncture, submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on March 28, 2025, 88 days after receiving the submission on December 30, 2024. This device falls under the Neurology review panel.

Submission Details

510(k) Number K244030 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2024
Decision Date March 28, 2025
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

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