FDA.reportPublic FDA data

Dynatron Solaris Plus 708

Primary DI
10660584000024
Brand
Dynatron Solaris Plus 708
Company
Dynatronics Corporation
Model
D718T
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
ILYLamp, Infrared, Therapeutic Heating
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
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep HeatPhysical Medicine2
IPFStimulator, Muscle, PoweredPhysical Medicine2
LIHInterferential Current TherapyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031329000DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)Dynatronics Corp.2003-10-22IMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10660584000024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1066058400002410660584000024

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality physical therapy systemAn assembly of electrically-powered devices designed to apply multiple different energies (e.g., light-energy, ultrasound, radio-frequency electrical stimulation, and microcurrent electrotherapy) either alone or in sequence, but not simultaneously, to noninvasively treat/prevent a variety of soft-tissue, neuromuscular, and musculoskeletal injuries/disorders (e.g., joint pain/inflammation, stiffness, soft tissue injuries, muscle atrophy, plantar fasciitis); it may in addition be used for aesthetic skin/body contouring (e.g., minimize cellulite, loose or wrinkled skin). It consists of a multi-modality control unit/generator, and dedicated applicators for the transcutaneous delivery of energy.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4Inch
Length12Inch
Weight8.2Pound
Width18.5Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8008746251info@dynatron.com

Regulatory Flags#

DUNS number
113399125
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10660584000017Dynatron Solaris Plus 709D719T2016-09-24
10660584000031Dynatron Solaris Plus 707D7172016-09-24
10660584000048Dynatron Solaris Plus 706D716T2016-09-24
10660584000055Dynatron Solaris Plus 705D715T2016-09-24
10660584000109Dynatron 25 Series 925BD925T2016-09-24
10660584000116Dynatron 25 Series 825BD825T2016-09-24
10660584000123Dynatron 25 Series 625BD625T2016-09-24
10660584000130Dynatron 25 Series 525BD525T2016-09-24
10660584000338Dynatron Solaris Plus 709D7192016-09-24
10660584000918DynaGel™ Ultrasound Gel, 5 Liters, Clear5LTRGEL5LTRGEL2016-11-18
10660584000222DynaGel™ Ultrasound Gel, 5 Liters, Blue5LTRGEL-B5LTRGEL-B2016-11-18
10660584000895DynaGel™ Ultrasound Gel, sample7B02177B02172016-11-18
10660584000901DynaGel™ Ultrasound Gel, 5 Liters, Blue5LTRGEL-B2018-10-18
10660584000925Dynatron® Lotion, 1 GallonDL1DL12016-11-18
10660584000277Dynatron Soundhead WSH022016-09-24
10660584000284Dynatron SoundheadWSH052016-09-24
10660584000291Dynatron Soundhead `WSH102016-09-24
10660584000185Solaris Soundhead9GSH022016-09-24
10660584000192Solaris Soundhead9GSH052016-09-24
10660584000208Solaris Soundhead9GSH102016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
G710L240Velara Lounge 24SUNSHINE USA, LLCILY2026-05-15
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
08800016213034PLASONICHironic Co., ltd.IMI2026-03-18
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
08032625824480GLOBUSDOMINO SRLLIH2026-02-23
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
G180DIOWAVESTEALTHLIT0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12