FDA.reportPublic FDA data

Element System with IBT Electrodes

Primary DI
00850004850022
Brand
Element System with IBT Electrodes
Company
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
Model
80101-3
Device description
Surface electrodes for Electromyography with controller - Dynamic Arm
Published
2021-02-23
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
GXYElectrode, Cutaneous
IQZHand, External Limb Component, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2
IQZHand, External Limb Component, PoweredPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173571000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173571000Element System with IBT ElectrodesInfinite Biomedical Technologies, LLC2018-03-21GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004850022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004850022008500048500228500048500220850004850022

GMDN Terms#

Term, Definition table
TermDefinition
Myoelectric hand prosthesisA powered artificial substitute for a missing hand that may be attached to a natural arm or used as part of an upper-limb external prosthetic system, and is designed to replace the appearance and some of the function of the hand. The device moves as the result of a motor(s) that may be integral or proximally mounted with a mechanical link. The control of movement is achieved through amplified muscle action potentials from voluntary contracting muscle in the residual limb/trunk, transmitted via surface electrodes in the device that make contact with the skin, which turn on the motor to provide a function.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4434517175support@i-biomed.com

Regulatory Flags#

DUNS number
037376022
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850004850879Glide94001-42025-03-20
00850004850886Glide94001-82025-03-20
00850004850626Glide91000-GL-B2024-04-30
00850004850633Glide91000-GL-C2024-04-30
00850004850640Glide91000-GL-D2024-04-30
00850004850657Glide91000-GL-E2024-04-30
00850004850664Glide91000-GL-F2024-04-30
00850004850671Glide91000-GL-G2024-04-30
00850004850688Glide91000-GL-H2024-04-30
00850004850695Glide91000-GL-I2024-04-30
00850004850701Glide91000-GL-J2024-04-30
00850004850718Glide91000-GL-K2024-04-30
00850004850725Glide91000-GL-L2024-04-30
00850004850732Glide91000-GL-M2024-04-30
00850004850749Glide91000-GL-N2024-04-30
00850004850756Glide940012024-04-30
00850004850763Glide95001-ST2024-04-30
00850004850770Glide90010-GL2024-04-30
00850004850787Glide90041-BK2024-04-30
00850004850794Glide90041-RD2024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973602730894MEDLOTTOP-RANK HEALTH CARE CO., LTD.GXY2026-06-08
08720791379032Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379049Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379063Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379087Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
00850055335004iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335011iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335028iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
08057971594795Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-20
08057971594801Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-20
08057971594818Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-20
08057971594733Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-18
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08057971594603Adam's HandBIONIT LABS SRLIQZ2025-12-17
08057971592463Adam's HandBIONIT LABS SRLIQZ2025-11-21
08057971593989Adam's SkinBIONIT LABS SRLIQZ2025-11-21
08057971594870Adam's HandBIONIT LABS SRLIQZ2025-11-05
08057971591442Adam's SkinBIONIT LABS SRLIQZ2025-10-28
08057971593781Adam's SkinBIONIT LABS SRLIQZ2025-10-28
08057971594085Analog Amplifier with accessoriesBIONIT LABS SRLIQZ2025-08-25
08057971594856Adam's HandBIONIT LABS SRLIQZ2025-07-11
08057971593804Adam's HandBIONIT LABS SRLIQZ2025-05-08
08057971593774Adam's HandBIONIT LABS SRLIQZ2025-04-03
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08057971592685Wave ElectrodeBIONIT LABS SRLIQZ2025-01-21
08057971590964Wave Electrode with accessoriesBIONIT LABS SRLIQZ2025-01-21
08057971590971Wave Electrode with accessoriesBIONIT LABS SRLIQZ2025-01-21
08057971592692Wave ElectrodeBIONIT LABS SRLIQZ2025-01-21