Glide

Basic Information

• Brand Name: Glide
• Primary DI: 00850004850695
• Version / Model: 91000-GL-I
• Company Name: INFINITE BIOMEDICAL TECHNOLOGIES, LLC
• Labeler DUNS: 037376022
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-30
• Public Version: 3
• Public Version Date: 2025-05-22
• Public Version Status: Update
• Public Device Record Key: c67ab447-2deb-49db-9fbe-c25b8aa2ca0c

Device Description

For the ErgoArm with direct grip control configurations

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IQZ	Hand, External Limb Component, Powered	Physical Medicine	890.3420	1
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41497	Myoelectric hand prosthesis	A 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 features an integral or proximally mounted motor (e.g., electric, hydraulic) which actuates hand/finger movements (e.g., gripping, pinching, pointing). 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.	No	Active
61020	Analytical non-scalp cutaneous electrode	An electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to/from a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850004850695	GS1

Premarket Submissions

Submission Number	Supplement Number
K240884	000