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Device Explorer · FDA GUDID · GMDN 35751

Transcutaneous electrical stimulation lead

A non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as

US‑registered devices301in commercial distribution
Companies30labelers on GUDID
Single‑use6%of device records
Sterile0%labelled sterile
Prescription11%Rx‑only share
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Share of device records

C.M.P. Canadian Medical Products Inc15652%
Djo, Llc3913%
Drive Devilbiss Healthcare227%
Avazzia Inc155%
Tens Plus Industrial Company145%
Medtronic Xomed, Inc.83%
Dynatronics Corporation83%
Fisher & Paykel Healthcare Limited41%

Top labelers

CompanyDevicesShare
C.M.P. Canadian Medical Products Inc15652%
Djo, Llc3913%
Drive Devilbiss Healthcare227%
Avazzia Inc155%
Tens Plus Industrial Company145%
Medtronic Xomed, Inc.83%
Dynatronics Corporation83%
Fisher & Paykel Healthcare Limited41%
Viora Ltd31%
Electromedical Products International, Inc.31%
Changsha Yuhong Trading Co., Ltd31%
Clinical Health Services, Inc.31%

Company = labeler of record on GUDID. 30 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Flat Single-Use TipBrush Single-Use TipDermaFuseInterm Cbl Trident (NMT), 1.9mNMT Cbl Trident, 2 lead, 0.3MCHATTANOOGACOMPEXPhoton BioAlpha-Stim Leadwire (PPM)Alpha-Stim Leadwire (AS100)Alpha-Stim Leadwire (ASM)Sharper ImageFamidocAvazziaColumbia ScientificAVCOO

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

FDA product codes

CodeNameDevices
IKDCable, Electrode215
IKDCABLE, ELECTRODE40
GZJStimulator, Nerve, Transcutaneous, For Pain Relief24
GXYELECTRODE, CUTANEOUS9
GXYElectrode, Cutaneous8
ISAMassager, Therapeutic, Electric5

GMDN & GCC registration

  • GMDN code 35751 · non‑implantable
  • Single‑use 6% · sterile 0% · Rx‑only 11% · OTC 69%
  • 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) · 9Length (Meter) · 7

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

How many transcutaneous electrical stimulation lead products are registered in the US?

301 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Transcutaneous electrical stimulation lead", from 30 companies. The largest labeler is C.M.P. Canadian Medical Products Inc with 52% of records.

Which FDA product codes apply?

IKD (Cable, Electrode), IKD (CABLE, ELECTRODE), GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), GXY (ELECTRODE, CUTANEOUS)

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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