FDA.reportPublic FDA data

Glide

Primary DI
00850004850886
Brand
Glide
Company
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
Model
94001-8
Device description
Glide Fabrication kit with 8 dummies
Published
2025-03-20
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
00850004850886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004850886008500048508868500048508860850004850886

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
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
00850004850800Glide90041-BL2024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378271Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378288Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378295Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378301Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378318Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378325Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378349Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378356Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378363Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378370Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378387Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378394Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378400Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378417Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378424Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378431Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378448Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08