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510(k) K182203

JKH Stimulator Plus by Jkh USA, LLC — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2019
Date Received
August 15, 2018
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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  • K201645 — Massage Compression Boots (September 15, 2020)
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  • K191151 — JKH Stimulator Plus (June 21, 2019)

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