FDA.reportPublic FDA data

Soleo SonoStim

Primary DI
04053815003304
Brand
Soleo SonoStim
Company
Zimmer MedizinSysteme GmbH
Model
5340
Catalog number
5340
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
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat
IPFStimulator, Muscle, Powered
LIHInterferential Current Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep HeatPhysical Medicine2
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep HeatPhysical Medicine2
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
04053815003304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053815003304040538150033044053815003304

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy ultrasound/neuromuscular stimulation systemAn assembly of devices that includes a neuromuscular electrical stimulator as an integral part of a therapeutic ultrasound system intended for the simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and to help reduce muscle spasms and pain; it may in addition be capable of delivering either energy alone. The system is designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments.

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
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
24053815072915Zimmertrodes87200171872001712021-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-29
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-29
08032625829843NerveOTXDOMINO SRLLIH2026-07-28
08032625829843NerveOTXDOMINO SRLIPF2026-07-28
08032625829843NerveOTXDOMINO SRLGZJ2026-07-28
00860015112446Doctor's Choice®CLINICAL HEALTH SERVICES, INC.GZJ2026-07-14
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-09
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-03
08809851470145WavefacialWEERO Co., Ltd.GZJ2026-06-22
08809851470145WavefacialWEERO Co., Ltd.IPF2026-06-22
G345SL2000CIONICCionic, Inc.IPF2026-06-04
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
04048223122235Stim2GoPajunk GmbH MedizintechnologieIPF2026-05-21
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13