510(k) clearance

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

FDA 510(k) source

510(k) number

K260230

Applicant

Suzhou Medical Appliance Factory

Decision date

Oct 22, 2026

Date received

Jan 26, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

BWK

Device type

Stimulator, Electro-Acupuncture

Device class

Unclassified

Advisory committee

Unknown

Statement or summary

Summary

Third party

N

Location

Suzhou, CN