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FDA 510(k)

Katalyst Training System

K-Number: K190966 · 2020-02-03

ApplicantKatalyst, Inc.
Decision Date2020-02-03
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Katalyst Training System is the device name listed in this FDA 510(k) record. The listed applicant is Katalyst, Inc.. It received FDA 510(k) clearance on 2020-02-03 under 510(k) number K190966. 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 Training System?

Katalyst Training System is a medical device that received FDA 510(k) clearance on 2020-02-03. The listed applicant is Katalyst, Inc.. The 510(k) number is K190966.

When did Katalyst Training System receive FDA 510(k) clearance?

Katalyst Training System received FDA 510(k) clearance on 2020-02-03, under 510(k) number K190966.

Who is the listed applicant for Katalyst Training System?

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 Training System?

The FDA product code for Katalyst Training System 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.

K181199Katalyst Mark 1 Muscle Stimulation System Model 2K171035Katalyst 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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