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510(k) K130802

OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) by Shenzhen Dongdixin Technology Co., Ltd. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2013
Date Received
March 22, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

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