UltraTENS— 510(k) K142976

Name: FDA 510(k) clearance K142976
Creator: U.S. Food and Drug Administration
Published: 2015-08-26

Substantially Equivalent

Shenzhen Dongdixin Technology Co., Ltd.

FDA 510(k) clearance K142976 for UltraTENS, Substantially Equivalent on 2015-08-26. Applicant: Shenzhen Dongdixin Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Dongdixin Technology Co., Ltd.
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2014-10-14
Decision date: 2015-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, 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.