FDA.reportPublic FDA data

Soleo Stim

Primary DI
04053815003328
Brand
Soleo Stim
Company
Zimmer MedizinSysteme GmbH
Model
5350
Catalog number
5350
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2
LIHInterferential Current TherapyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121059000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121059000SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIMZimmer Medizinsystems GmbH2012-08-07IMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053815003328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053815003328040538150033284053815003328

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy electrical stimulation system, line-poweredAn assembly of mains electricity (AC-powered) devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical calf muscle stimulation to prevent venous thrombosis, and/or to maintain or increase range of motion.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 327-3576info@zimmerusa.com

Regulatory Flags#

DUNS number
316111251
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053815003304Soleo SonoStim534053402016-09-24
04053915986880Tecarpuls II173193117319312026-02-12
04053815076698CoolTone5034CS-MS-002-D-002019-12-04
04053815088325Endolaser HP163693146972025-03-17
04053815088332EndoPuls 811165090354352025-03-17
04053815087410ZStimPTG-0562222024-07-29
04053815086369ZShapeRFG-0155702024-07-19
04053815087229Cryo 7737573752024-05-27
04053815076711MFG-05503650362023-10-16
04053815081296ThermoTK480248022023-06-05
04053815083344clTrac514351432023-06-05
04053815980254OptonPro 25W468746872020-10-23
04053815053972OptonPro468246822016-09-24
04053815079187CoolTone5040CS-MS-002-D-CA2022-09-15
04053815078562emField503850382022-05-11
04053815080848Cryo 7737073702022-03-01
14053815072918Zimmertrodes87200171872001712021-03-10
14053815072925Zimmertrodes87200172872001722021-03-10
14053815072932Zimmertrodes87200173872001732021-03-10
14053815072949Zimmertrodes87200174872001742021-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G345SL2000CIONICCionic, Inc.IPF2026-06-04
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
08032625824480GLOBUSDOMINO SRLLIH2026-02-23
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
08032625822868GLOBUSDOMINO SRLLIH2024-11-20
08032625822875GLOBUSDOMINO SRLIPF2024-11-20
08032625822875GLOBUSDOMINO SRLLIH2024-11-20
08032625822882GLOBUSDOMINO SRLIPF2024-11-20
08032625822882GLOBUSDOMINO SRLLIH2024-11-20
08809851470053eMVFitWEERO Co., Ltd.IPF2024-10-22