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510(k) K171978

Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 by Shenzhen Dongdixin Technology Co., Ltd. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2017
Date Received
June 30, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

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