FDA.reportPublic FDA data

Stimulation System

Primary DI
06944413866171
Brand
Stimulation System
Company
Edan Instruments, Inc.
Model
PA36
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232786000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232786000Stimulation System (PA series, PR series, S series and Q series)Edan Instruments, Inc.2024-05-16IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944413866171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944413866171069444138661716944413866171

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Regulatory Flags#

DUNS number
529173163
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944413817210Connection Cable01.57.4721782026-05-19
06944413817234 Connection Cable01.57.4722162026-05-19
06944413820050EMG/Stimulation sensor01.57.4726242026-05-19
06944413820074EMG/Stimulation sensor01.57.4726312026-05-19
06944413825475Connection Cable01.57.4722812026-05-19
06944413825482Connection Cable01.57.4723812026-05-19
06944413834026EMG/Stimulation sensor01.57.4726252026-05-19
06944413834736EMG/Stimulation sensor01.57.472623 2026-05-19
06944413866133Stimulation SystemPR362026-05-15
06944413866140Stimulation SystemPR382026-05-15
06944413866157Stimulation SystemPR4 Pro2026-05-15
06944413866164Stimulation SystemPR42026-05-15
06944413866188Stimulation SystemPA382026-05-15
06944413866195Stimulation SystemPA4 Pro2026-05-15
06944413866201Stimulation SystemPA42026-05-15
06944413866218Stimulation SystemQ32026-05-15
06944413866225Stimulation SystemQ92026-05-15
06944413866232Stimulation SystemQ102026-05-15
06944413866249Stimulation SystemQ122026-05-15
06944413866256Stimulation SystemS62026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
08720618311139Sonopuls 494Enraf-Nonius B.V.IPF2025-02-11
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
08032625822868GLOBUSDOMINO SRLIPF2024-11-20
08032625822875GLOBUSDOMINO SRLIPF2024-11-20
08032625822882GLOBUSDOMINO SRLIPF2024-11-20
08809851470053eMVFitWEERO Co., Ltd.IPF2024-10-22
08032625822851GLOBUSDOMINO SRLIPF2024-10-17
08032625828037GLOBUSDOMINO SRLIPF2024-10-17
08032625829799GLOBUSDOMINO SRLIPF2024-10-17
08032625829805GLOBUSDOMINO SRLIPF2024-10-17
08032625829812GLOBUSDOMINO SRLIPF2024-10-17
B108899PO11C1ENUS0150EMSCULPT NEOBTL INDUSTRIES LIMITEDIPF2024-09-23