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510(k) K181645

StimaWELL 120MTRS by Pierenkemper GmbH — Product Code GZJ

K181645 is an FDA 510(k) premarket notification submitted by Pierenkemper GmbH for the device "StimaWELL 120MTRS". The FDA issued a decision of Substantially Equivalent on August 13, 2020. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2020
Date Received
June 22, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

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FDA data resources