DX6605E-TENS, DX6605E-G, DX6609-G— 510(k) K082057

Name: FDA 510(k) clearance K082057
Creator: U.S. Food and Drug Administration
Published: 2009-02-26

Substantially Equivalent

Shenzhen Dongdixin Technology Co., Ltd.

FDA 510(k) clearance K082057 for DX6605E-TENS, DX6605E-G, DX6609-G, Substantially Equivalent on 2009-02-26. Applicant: Shenzhen Dongdixin Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Dongdixin Technology Co., Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2008-07-21
Decision date: 2009-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, Bao'An District, CN

Download summary PDF View on FDA.gov ↗

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