CT2011 SONICSTIMU PAIN RELIEF DEVICE— 510(k) K092627

Name: FDA 510(k) clearance K092627
Creator: U.S. Food and Drug Administration
Published: 2010-01-14

Substantially Equivalent

Shenzhen Dongdixin Technology Co., Ltd.

FDA 510(k) clearance K092627 for CT2011 SONICSTIMU PAIN RELIEF DEVICE, Substantially Equivalent on 2010-01-14. Applicant: Shenzhen Dongdixin Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Dongdixin Technology Co., Ltd.
Product code: Code IMG
Device class: Class 2
Regulation: 21 CFR 890.5860
Advisory panel: Physical Medicine
Date received: 2009-08-26
Decision date: 2010-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, Guangdong, CN

Download summary PDF View on FDA.gov ↗

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