FDA.reportPublic FDA data

N/A

Primary DI
10841898137211
Brand
N/A
Company
INNOVATIVE HEALTH LLC
Model
N/A
Catalog number
401748
Device description
Threshold Cable 240 cm
Published
2026-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

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
10841898137211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084189813721110841898137211

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reprocessedA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a single-use device previously used that has been reprocessed for an additional single-use patient application.

Contacts#

Phone, Email table
PhoneEmail
877-400-3740regulatory@innovative-health.com

Regulatory Flags#

DUNS number
015575953
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841898135972N/AN/AD-AVHDX-DF162026-10-05
10841898137365N/AN/AVXAK93D1-DIL2026-07-10
10841898137372N/AN/AVXAK85D0-DIL2026-07-10
10841898137389N/AN/AVXAK85D1-DIL2026-07-10
10841898137273N/AN/A116574842026-06-01
10841898137280N/AN/A116574852026-06-01
10841898137174N/AN/A115108262026-05-07
10841898137266N/AN/A115108252026-05-07
10841898137297N/AN/AVXW-35-230-J2026-05-07
10841898137303N/AN/AVXW-35-180-J2026-05-07
10841898137310N/AN/AVXW-35-230-P2026-05-07
10841898137327N/AN/AVXW-35-180-P2026-05-07
10841898137587N/AN/AVXW-CFD-180J2026-05-07
10841898137594N/AN/AVXW-CFD-180P2026-05-07
10841898137600N/AN/AVXW-CFD-230P2026-05-07
10841898137617N/AN/AVXW-CWM-180J2026-05-07
10841898137624N/AN/AVXW-CWM-180P2026-05-07
10841898137631N/AN/AVXW-CWM-230P2026-05-07
10841898137242N/AN/AD1337032026-04-17
10841898123214N/AN/A104392362018-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572108APKAPK Technology Co.,Ltd.IKD2026-10-13
06946725572115APKAPK Technology Co.,Ltd.IKD2026-10-13
06946725572122APKAPK Technology Co.,Ltd.IKD2026-10-13
06946725571712APKAPK Technology Co.,Ltd.IKD2026-07-01
06946725500866APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500873APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500880APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500897APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500903APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500910APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500927APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500934APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500941APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500958APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500965APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500972APKAPK Technology Co.,Ltd.IKD2025-07-22
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