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Device Explorer · FDA GUDID · GMDN 65318

Transcutaneous electrical stimulation electrode, reusable

An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electro

US‑registered devices317in commercial distribution
Companies26labelers on GUDID
Single‑use6%of device records
Sterile2%labelled sterile
Prescription59%Rx‑only share
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Share of device records

Gmdasz Manufacturing Co., Ltd.10232%
Everyway Medical Instruments Co., Ltd.4715%
Bozhou Rongjian Medical Appliance Co., Ltd.165%
Uan Healthcare Limited165%
South Dakota Partners Inc.165%
Bioness Inc.155%
Biowave Corporation144%
Bioness Medical, Inc.134%

Top labelers

CompanyDevicesShare
Gmdasz Manufacturing Co., Ltd.10232%
Everyway Medical Instruments Co., Ltd.4715%
Bozhou Rongjian Medical Appliance Co., Ltd.165%
Uan Healthcare Limited165%
South Dakota Partners Inc.165%
Bioness Inc.155%
Biowave Corporation144%
Bioness Medical, Inc.134%
Axion Usa Llc124%
Hi-Dow International Incorporated103%
Clearlake-Tech Inc.103%
Shenzhen Roundwhale Technology Co. Ltd.93%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

QIJIUPremium Gel White Fabri ElectrodesROOVJOYAUVONNAAVCOOdiscount TENSMyocene ElectrodeEverywayFORTIS MEDICAL DEVICES LIMITEDPain ManagementEVERYWAY4ALLAxionBioWave BLUE Knee BioWrap S/MBioWave Noninvasive Velcro Backed Electrodes - BBioWave BLUE Knee BioWrap L/XL

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

FDA product codes

CodeNameDevices
GXYElectrode, Cutaneous290
IPFStimulator, Muscle, Powered16
GZISTIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL13
IPFStimulator, muscle, powered13
GZIStimulator, Neuromuscular, External Functional13
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter4

GMDN & GCC registration

  • GMDN code 65318 · non‑implantable
  • Single‑use 6% · sterile 2% · Rx‑only 59% · OTC 63%
  • 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 transcutaneous electrical stimulation electrode, reusable products are registered in the US?

317 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Transcutaneous electrical stimulation electrode, reusable", from 26 companies. The largest labeler is Gmdasz Manufacturing Co., Ltd. with 32% of records.

Which FDA product codes apply?

GXY (Electrode, Cutaneous), IPF (Stimulator, Muscle, Powered), GZI (STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL), IPF (Stimulator, muscle, powered)

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.

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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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