UltraTENS— 510(k) K142976

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..

Clearance details

Applicant: Shenzhen Dongdixin Technology Co., Ltd.
Product code: Code IMI
Advisory panel: Physical Medicine
Date received: 2014-10-14
Decision date: 2015-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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