FDA.reportPublic FDA data

Glide

Primary DI
00850004850671
Brand
Glide
Company
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
Model
91000-GL-G
Device description
For the Steeper Espire Classic Plus elbow configurations
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
00850004850671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004850671008500048506718500048506710850004850671

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
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
00850004850800Glide90041-BL2024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08057971595815Adam's Hand PlusBIONIT LABS SRLIQZ2026-08-07
08057971595822Adam's Hand PlusBIONIT LABS SRLIQZ2026-08-07
08057971596416Adam's Hand PlusBIONIT LABS SRLIQZ2026-08-07
08057971596423Adam's Hand PlusBIONIT LABS SRLIQZ2026-08-07
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08