Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V)— 510(k) K260230

Name: FDA 510(k) clearance K260230
Creator: U.S. Food and Drug Administration
Published: 2026-10-22

Substantially Equivalent

Suzhou Medical Appliance Factory

FDA 510(k) clearance K260230 for Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V), Substantially Equivalent on 2026-10-22. Applicant: Suzhou Medical Appliance Factory. Device class: Unclassified.

Clearance details

Applicant: Suzhou Medical Appliance Factory
Product code: Product code BWK
Device class: Unclassified
Advisory panel: Unknown
Date received: 2026-01-26
Decision date: 2026-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code BWK

view all

K244030 — Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)2025-03-28
K220153 — Needle Stimulator (Model: RJNS6-1)2022-03-18
K202861 — Needle Stimulator2021-08-27
K200636 — AXUS ES-5 Electro-Acupuncture Device2021-02-03
K170391 — ANSiStim-PP2017-03-09

More clearances from Suzhou Medical Appliance Factory

view all

K063568 — HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL2007-03-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.