FDA.reportPublic FDA data

Glide

Primary DI
00850004850831
Brand
Glide
Company
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
Model
90041-PR
Device description
IBT Remote Dome Electrode - Purple
Published
2024-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
K240884000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240884000Glide (91000-GL-X)Infinite Biomedical Technologies, LLC2024-04-15GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004850831PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004850831008500048508318500048508310850004850831

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

Regulatory Flags#

DUNS number
037376022
Device count
1
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
00382830063821NatusXLTEKGXY2026-10-15
00382830063838NatusXLTEKGXY2026-10-15
00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
06973602731105Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731112Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731129Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
00850080988718AUVONUAN HEALTHCARE LIMITEDGXY2026-10-08
05905515340793MyoSenseAETHER BIOMEDICAL SP Z O OIQZ2026-10-08
05905515340618ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340632ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340717ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340731ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340755ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340779ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340816ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340830ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08057971595792Adam's Hand PlusBIONIT LABS SRLIQZ2026-08-07
08057971595808Adam's Hand PlusBIONIT LABS SRLIQZ2026-08-07