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FDA 510(k)

Bemer Therapy System Evo

K-Number: K231368 · 2023-06-09

ApplicantBemer Int AG
Decision Date2023-06-09
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Bemer Therapy System Evo is a medical device manufactured by Bemer Int AG. It received FDA 510(k) clearance on 2023-06-09 under approval number K231368. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bemer Therapy System Evo?

Bemer Therapy System Evo is a medical device that received FDA 510(k) clearance on 2023-06-09. It is manufactured by Bemer Int AG. The 510(k) number is K231368.

When was Bemer Therapy System Evo approved by the FDA?

Bemer Therapy System Evo received FDA 510(k) clearance on 2023-06-09, under approval number K231368.

What company makes Bemer Therapy System Evo?

Bemer Therapy System Evo is manufactured by Bemer Int AG.

What is the FDA product code for Bemer Therapy System Evo?

The FDA product code for Bemer Therapy System Evo is NGX.

Related Clinical Trials

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018)

Other Devices by Bemer Int AG

K151834BEMER Classic Set, BEMER Pro-Set K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set K223919B.Light Clear Evo and B.Light Restore Evo

Related Devices (Code: NGX)

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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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