Cleared Traditional

K260230 - Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V)

K260230 · Suzhou Medical Appliance Factory · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
269d
Days
-
Risk

K260230 is an FDA 510(k) clearance for the Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V). Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Suzhou Medical Appliance Factory (Suzhou, CN). The FDA issued a Cleared decision on October 22, 2026 after a review of 269 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K260230

510(k) Number K260230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2026
Decision Date October 22, 2026
Days to Decision 269 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
120d slower than avg
Panel avg: 149d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

BWK Device Classification - Class 0,

Product Code BWK Stimulator, Electro-acupuncture
Device Class -

Regulatory Consultant

Abmed Medical Technology Pty, Ltd.
Boyle Wang

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.

Regulatory Peers - BWK Stimulator, Electro-acupuncture

All 23
Devices cleared under the same product code (BWK) and FDA review panel - the closest regulatory comparables to K260230.
Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
K244030 · Wuxi Jiajian Medical Instrument Co., Ltd. · Mar 2025
Needle Stimulator (Model: RJNS6-1)
K220153 · Bozhou Rongjian Medical Appliance Co., Ltd. · Mar 2022
Needle Stimulator
K202861 · Wuxi Jiajian Medical Instrument Co., Ltd. · Aug 2021
AXUS ES-5 Electro-Acupuncture Device
K200636 · Lhasa Oms, Inc. · Feb 2021
ANSiStim-PP
K170391 · Dyansys, Inc. · Mar 2017
Stivax
K152571 · Biegler GmbH · May 2016
K260230 · Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V)
Download PDF FDA Summary Suzhou Medical Applia…