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510(k) K142976

UltraTENS by Shenzhen Dongdixin Technology Co., Ltd. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2015
Date Received
October 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

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