FDA.reportPublic FDA data

EMPI Focus 2 Channel Stimulator

Primary DI
B36711001L00
Brand
EMPI Focus 2 Channel Stimulator
Company
AXIOBIONICS
Model
0
Catalog number
11001
Device description
Neuromuscular Stimulator
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZIStimulator, Neuromuscular, External Functional
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951951000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951951000FOCUS MODEL 795 UNITEmpi1996-05-17GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B36711001L00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit 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. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033139835
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B36711002L00Axio 2 Channel Stimulator0110022016-09-24
B3671100300Axio 4 Channel Stimulator0110032016-09-24
B36711008L00EMPI 300PV Stimulator0110082016-09-24
B36711402L00EMPI Continuum0114022016-09-24
B36712159L00OOFS Pace XL Stimulator012159L2018-12-27
B3673350UE BioSleeve5332021-01-08
B3670030BioCollar3002016-09-24
B3670040BioCollar4002017-02-20
B3670100BioMiniVest0012016-09-24
B3670210BioVest1022016-09-24
B3670320BioUnitard2032016-09-24
B3670440BioMiniBelt4042016-09-24
B3670530BioBelt Lumbar3052016-09-24
B3670610BioBelt Lumbar Contoured1062016-09-24
B3670700BioBelt Ab0072016-09-24
B367080BioBelt Ab Large Expanded0082017-05-22
B367100M00Adhesive Electrode0100M2016-09-24
B367115P20BioGel Velcro Electrode2115P2016-09-24
B367116P20BioGel Velcro Electrode2116P2016-09-24
B367117P20BioGel Velcro Electrode2117P2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
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 MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
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