510(k) clearances

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

Suzhou Medical Appliance Factory · Unknown

K260230Substantially EquivalentTraditionalBWK
Open FDA's page for this record
Third party flag
N
City
Suzhou
Advisory committee description
Unknown
Address 1
#18 Huatuo Rd., Sstt, 215163 Suzhou New District
Statement or summary
Summary
Product code
BWK
Zip code
215163
Applicant
Suzhou Medical Appliance Factory
Decision date
2026-10-22
Decision code
SESE
Country code
CN
Device name
Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V)
Contact
Xuejiao Song
K number
K260230
Date received
2026-01-26
Review advisory committee
NE
Postal code
215163
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Stimulator, Electro-Acupuncture
Medical specialty description
Unknown
Device class
U
Registration number
3007710601, 3001110146, 3010350335, 3010363503, 3023237645, 3009445917, 2939821, 3003755374, 9614750, 8043792, 3003836669, 3012184208, 9613446, 3011743372
FEI number
1000533128, 3007710601, 3001110146, 3010350335, 3010363503, 3023237645, 3002808269, 3003755374, 1000124207, 3003836669, 3012184208, 3004546558, 3011743372, 3009293069
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.