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510(k) K133929

HEALTH EXPERT ELCTRONIC STIMULATOR by Shenzhen Osto Technology Company Limited — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2014
Date Received
December 23, 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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  • K190783 — Health Expert Electronic Stimulator (model: AST-300L) (March 14, 2020)
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