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Device Explorer · FDA GUDID · GMDN 63313

Kinesiology/electromyographic sensor set

A collection of patient-worn devices consisting of both an electromyographic sensor and motion-based sensor intended to be used in a clinical setting as part of a system (e.g., virtual-display rehabilitation system, biomechanical analysis system) to provide no

US‑registered devices91in commercial distribution
Companies9labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription37%Rx‑only share
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Share of device records

Noraxon U.S.A., Inc.4853%
Medidata Solutions, Inc.2123%
Biometrics Limited78%
Ncs Lab Srl78%
Prometheus Group Of New Hampshire Limited, The33%
Srs Medical Systems, Inc.22%
Aether Biomedical Sp Z O O11%
Neurosoft, Ooo11%

Top labelers

CompanyDevicesShare
Noraxon U.S.A., Inc.4853%
Medidata Solutions, Inc.2123%
Biometrics Limited78%
Ncs Lab Srl78%
Prometheus Group Of New Hampshire Limited, The33%
Srs Medical Systems, Inc.22%
Aether Biomedical Sp Z O O11%
Neurosoft, Ooo11%
Neurofield, Inc.11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MyoSenseE-LINK Myo-EX GX2 EMG SensorE-LINK Myo-EX GX1 EMG SensorE-LINK Myo-EX GX4 EMG SensorE-LINK Myo-EX GX3 EMG SensorE-LINK Myo-EX GX5 Wireless EMG SensorSteadys-StepEMG SensorInsight Discovery EMGNeuroField X3000N/APathwayUltiumUltium / CoreCoreNoraxon

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
HCCDevice, Biofeedback59
IKNElectromyograph, Diagnostic46
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio44
LELDevice, Sleep Assessment44
DRGTransmitters And Receivers, Physiological Signal, Radiofrequ44
KQXGoniometer, Ac-Powered22

GMDN & GCC registration

  • GMDN code 63313 · non‑implantable
  • Single‑use 3% · sterile 0% · Rx‑only 37% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many kinesiology/electromyographic sensor set products are registered in the US?

91 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Kinesiology/electromyographic sensor set", from 9 companies. The largest labeler is Noraxon U.S.A., Inc. with 53% of records.

Which FDA product codes apply?

HCC (Device, Biofeedback), IKN (Electromyograph, Diagnostic), MWI (Monitor, Physiological, Patient (Without Arrhythmia Detectio), LEL (Device, Sleep Assessment)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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