K6-1 Diagnostic System Version 3.1

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K944134 ↗

FDA Product Code

KZM

Device Class

Class II

Regulation

21 CFR Part 890.1375

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Ms-100 Myo-Scanner or Ms-100 EMG Scanner

  Class II

  FDA 510(k) K921919 Active Cleared 7 Jan 1993

• Electrosonogram Esg-1

  Class I

  FDA 510(k) K905449 Active Cleared 26 Apr 1991

• Esg-1 Electrosonogram (Esg-1)

  Class I

  FDA 510(k) K970116 Active Cleared 2 Apr 1997

• Physiotech 4000 or Norodyn 8000

  Class II

  FDA 510(k) K922270 Active Cleared 2 Sep 1994

• K6-I Diagnostic System

  Class II

  FDA 510(k) K922456 Active Cleared 9 Jun 1994

• What is the K6-1 Diagnostic System Version 3.1 used for?

  The K6-1 Diagnostic System Version 3.1 is a device designed for muscle monitoring in physical medicine, assisting in diagnostic procedures. It is specifically intended for use in dental and neurology applications.

• How is the K6-1 Diagnostic System Version 3.1 supplied?

  The K6-1 Diagnostic System Version 3.1 is supplied by Myo-Tronics, Inc. It is not specified as single-use or reusable in the available information.

• What is the regulatory status of the K6-1 Diagnostic System Version 3.1?

  The K6-1 Diagnostic System Version 3.1 has FDA 510K clearance with product code KZM. It is classified as a Class II device and received its clearance through the traditional review process.

• What are the specifications of the K6-1 Diagnostic System Version 3.1?

  The K6-1 Diagnostic System Version 3.1 is a muscle monitoring device with FDA clearance number K944134. It was reviewed by the Physical Medicine advisory committee and received a decision code of SESE, indicating it was found to be substantially equivalent to predicate devices.