Glide

FDA UDI

Class I (US FDA UDI)

by Infinite Biomedical Technologies LLC

Identity

Trade Name: Glide FDA UDI
Generic Name: Myoelectric hand prosthesis FDA UDI
Device Name: IBT Remote Dome Electrode - Gray FDA UDI
Model / Reference: 90041-GY FDA UDI
Description: IBT Remote Dome Electrode - Gray FDA UDI

Identifiers

Primary DI / UDI-DI: 00850004850855 FDA UDI
510(k) Number: K240884 FDA UDI
FDA Product Code: IQZ FDA UDI
GXY FDA UDI
GMDN Term: Myoelectric hand prosthesis FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3420 FDA UDI
882.1320 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Analytical non-scalp cutaneous electrode Myoelectric hand prosthesis

Glide by Infinite Biomedical Technologies LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Myoelectric hand prosthesis.

Remote Electrode — Otto Bock Healthcare Products GmbH · Class II
S-CHARGE — HUGH STEEPER LIMITED · Class I
Luke Replaceable Part — MOBIUS BIONICS LLC · Class II
Luke Replaceable Part — MOBIUS BIONICS LLC · Class II
BATTERY SYSTEM — HUGH STEEPER LIMITED · Class I
Luke Replaceable Part — MOBIUS BIONICS LLC · Class II
Luke Replaceable Part — MOBIUS BIONICS LLC · Class II
Remote Electrode — Otto Bock Healthcare Products GmbH · Class II

Cleared under the same submission

K240884 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Infinite Biomedical Technologies LLC

Sources (1)

FDA UDI 7e2ad2c4-467f-4262-80f5-9da69c3d2ade 34 fields · synced May 30, 2026