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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 the device name listed in this FDA 510(k) record. The listed applicant is Katalyst, Inc.. It received FDA 510(k) clearance on 2018-09-20 under 510(k) 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. The listed applicant is Katalyst, Inc.. The 510(k) number is K181199.

When did Katalyst Mark 1 Muscle Stimulation System Model 2 receive FDA 510(k) clearance?

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

Who is the listed applicant for Katalyst Mark 1 Muscle Stimulation System Model 2?

The FDA 510(k) record lists Katalyst, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Katalyst, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190966Katalyst Training SystemK171035Katalyst Mark 1 Muscle Stimulation System

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

Official Source

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

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