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FDA 510(k)

Katalyst Mark 1 Muscle Stimulation System Model 2

K-Number: K181199 · 2018-09-20

ApplicantKatalyst, Inc.
Decision Date2018-09-20
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Katalyst Mark 1 Muscle Stimulation System Model 2 is a medical device manufactured by Katalyst, Inc.. It received FDA 510(k) clearance on 2018-09-20 under approval number K181199. 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 Katalyst Mark 1 Muscle Stimulation System Model 2?

Katalyst Mark 1 Muscle Stimulation System Model 2 is a medical device that received FDA 510(k) clearance on 2018-09-20. It is manufactured by Katalyst, Inc.. The 510(k) number is K181199.

When was Katalyst Mark 1 Muscle Stimulation System Model 2 approved by the FDA?

Katalyst Mark 1 Muscle Stimulation System Model 2 received FDA 510(k) clearance on 2018-09-20, under approval number K181199.

What company makes Katalyst Mark 1 Muscle Stimulation System Model 2?

Katalyst Mark 1 Muscle Stimulation System Model 2 is manufactured by Katalyst, Inc..

What is the FDA product code for Katalyst Mark 1 Muscle Stimulation System Model 2?

The FDA product code for Katalyst Mark 1 Muscle Stimulation System Model 2 is NGX.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026)

Other Devices by Katalyst, Inc.

K171035Katalyst Mark 1 Muscle Stimulation System K190966Katalyst Training System

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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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