Cleared Traditional

K244030 - Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (FDA 510(k) Clearance)

K244030 · Wuxi Jiajian Medical Instrument Co., Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2025
Decision
88d
Days
-
Risk

K244030 is an FDA 510(k) clearance for the Needle Stimulator (CMNS6-1 PLUS, CMNS6-3). Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on March 28, 2025 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wuxi Jiajian Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K244030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 148d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWK Stimulator, Electro-acupuncture
Device Class -

Regulatory Consultant

Shanghai CV Technology Co., Ltd.
Doris Dong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.