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FDA 510(k)

StimaWELL 120MTRS

K-Number: K181645 · 2020-08-13

ApplicantPierenkemper GmbH
Decision Date2020-08-13
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StimaWELL 120MTRS is a medical device manufactured by Pierenkemper GmbH. It received FDA 510(k) clearance on 2020-08-13 under approval number K181645. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StimaWELL 120MTRS?

StimaWELL 120MTRS is a medical device that received FDA 510(k) clearance on 2020-08-13. It is manufactured by Pierenkemper GmbH. The 510(k) number is K181645.

When was StimaWELL 120MTRS approved by the FDA?

StimaWELL 120MTRS received FDA 510(k) clearance on 2020-08-13, under approval number K181645.

What company makes StimaWELL 120MTRS?

StimaWELL 120MTRS is manufactured by Pierenkemper GmbH.

What is the FDA product code for StimaWELL 120MTRS?

The FDA product code for StimaWELL 120MTRS is GZJ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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