StimaWELL 120MTRS

Stimulator, Nerve, Transcutaneous, For Pain Relief

Pierenkemper GmbH

The following data is part of a premarket notification filed by Pierenkemper Gmbh with the FDA for Stimawell 120mtrs.

Pre-market Notification Details

Device IDK181645
510k NumberK181645
Device Name:StimaWELL 120MTRS
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant Pierenkemper GmbH Am Geiersberg 6 Ehringshausen,  DE 35630
ContactThorsten Reichel
CorrespondentAndre Kindsvater
Emergo Global Consulting 2500 Bee Cave Rd, Building 1, Suite 300 Austin,  TX  78746
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-22
Decision Date2020-08-13

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