FDA.reportPublic FDA data

"96"" SHROUDED PATIENT LEAD, BLACK"

Primary DI
10660584000529
Brand
"96"" SHROUDED PATIENT LEAD, BLACK"
Company
Dynatronics Corporation
Model
7B03030
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10660584000529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1066058400052910660584000529

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation leadA non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length96Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature41 Degrees Fahrenheit80.6 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
8008746251info@dynatron.com

Regulatory Flags#

DUNS number
113399125
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10660584000017Dynatron Solaris Plus 709D719T2016-09-24
10660584000024Dynatron Solaris Plus 708D718T2016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725502341APKAPK Technology Co.,Ltd.IKD2026-10-22
06946725500989APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500996APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501009APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501016APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501030APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501047APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501054APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501061APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501078APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501085APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501092APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501108APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501115APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501122APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501139APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501146APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501153APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501160APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501177APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501184APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501191APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501207APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501214APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501221APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501238APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501245APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501252APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501269APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501276APKAPK Technology Co.,Ltd.IKD2025-07-22