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Device Explorer · FDA GUDID · GMDN 35995

Transcutaneous electrical stimulation electrode, single-use

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 devices1,958in commercial distribution
Companies113labelers on GUDID
Single‑use33%of device records
Sterile5%labelled sterile
Prescription43%Rx‑only share
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Share of device records

Drive Devilbiss Healthcare37919%
Pro Medical Supplies, Inc.985%
Axelgaard Manufacturing Co., Ltd.895%
Shenzhen Yuwen E-Commerce Co., Ltd.874%
Emsi864%
Pepin Manufacturing, Inc.754%
Djo, Llc724%
Performance Health Supply, Llc663%

Top labelers

CompanyDevicesShare
Drive Devilbiss Healthcare37919%
Pro Medical Supplies, Inc.985%
Axelgaard Manufacturing Co., Ltd.895%
Shenzhen Yuwen E-Commerce Co., Ltd.874%
Emsi864%
Pepin Manufacturing, Inc.754%
Djo, Llc724%
Performance Health Supply, Llc663%
Neurotron Medical, Inc.553%
Biomedical Life Systems, Inc.543%
Axiobionics533%
Boxout, Llc503%

Company = labeler of record on GUDID. 113 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Livia - Flower Pads (White - Long Wire)Livia - Flower Pads (Black)Livia - flower-padsThree degreesBodi-TekVONMIEEMS BeltAB FLEXPohakuROOVJOYAUVONKonmedDR -HOSBelifuFamidocNA

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

FDA product codes

CodeNameDevices
GXYElectrode, Cutaneous1,991
GXYELECTRODE, CUTANEOUS175
GXYElectrode, cutaneous62
GZJStimulator, Nerve, Transcutaneous, For Pain Relief55
IPFStimulator, Muscle, Powered54
NGXStimulator, Muscle, Powered, For Muscle Conditioning50

GMDN & GCC registration

  • GMDN code 35995 · non‑implantable
  • Single‑use 33% · sterile 5% · Rx‑only 43% · OTC 41%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 112Width (Inch) · 101Area/Surface Area (Square inch) · 62Outer Diameter (Inch) · 33Width (Millimeter) · 20Length (Millimeter) · 20

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

How many transcutaneous electrical stimulation electrode, single-use products are registered in the US?

1,958 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Transcutaneous electrical stimulation electrode, single-use", from 113 companies. The largest labeler is Drive Devilbiss Healthcare with 19% of records.

Which FDA product codes apply?

GXY (Electrode, Cutaneous), GXY (ELECTRODE, CUTANEOUS), GXY (Electrode, cutaneous), GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)

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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