Identifiers
- 510(k) Number
- K240884 FDA 510(k)
- FDA Product Code
- GXY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1320 FDA 510(k)
- Regulation Number
- 882.1320 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Glide (91000-GL-X) is a myoelectric hand prosthesis designed for exoprosthetic fittings of the upper limb. This device is intended to assist individuals with upper limb amputation by providing functional hand movement through myoelectric control signals.
The Glide (91000-GL-X) is supplied by Infinite Biomedical Technologies LLC and has received FDA 510(k) clearance under the product code GXY. It is intended for single-use or reusable applications in clinical settings, with regulatory compliance confirmed through the FDA’s Substantial Equivalence determination in the Neurology advisory committee review.
Frequently asked questions
What types of upper limb amputations is the Glide (91000-GL-X) designed to assist with, and how does it work?
The Glide (91000-GL-X) is a myoelectric hand prosthesis specifically designed for exoprosthetic fittings of the upper limb, meaning it is intended for individuals with amputations of the hand or wrist. It functions by translating myoelectric control signals—electrical impulses generated by the remaining muscles in the user’s arm—into functional hand movements, restoring basic grip and dexterity.
Is the Glide (91000-GL-X) intended for single-use or reusable applications, and how does that affect its clinical use?
The Glide (91000-GL-X) is explicitly designed for both single-use and reusable applications in clinical settings. This flexibility allows clinicians to choose the most practical option based on patient needs, facility protocols, and cost considerations. Reusability may extend the device’s lifespan in controlled environments, while single-use ensures hygiene for patients requiring immediate or temporary fitting.
What regulatory pathway did the Glide (91000-GL-X) follow to gain market authorization, and what does that mean for its safety and compliance?
The Glide (91000-GL-X) received FDA 510(k) clearance under the product code GXY, determined to be *substantially equivalent* to a legally marketed predicate device through a traditional review process. This means the FDA evaluated it against existing standards for myoelectric prostheses and confirmed its safety, effectiveness, and compliance with U.S. regulations before authorization. The clearance was also reviewed by the Neurology Advisory Committee (NE), ensuring expert input on its clinical relevance.
How is the Glide (91000-GL-X) supplied, and are there any specific storage requirements mentioned for maintaining its functionality?
The Glide (91000-GL-X) is supplied by Infinite Biomedical Technologies LLC as a complete myoelectric hand prosthesis system, though exact packaging details (e.g., sterile packaging, accessories) are not specified in the provided data. For reusable units, proper cleaning and maintenance protocols would be critical to preserve functionality, while single-use units would rely on sterile packaging to ensure patient safety. Always follow manufacturer guidelines for storage to prevent damage or degradation of components.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K240884 - Glide (91000-GL-X) - Neurology, Glide (91000-GL-X) (K240884) — FDA 510 (k) | Innolitics, Glide (91000-GL-X) - FDA 510 (k) K240884 | MedTracker, PDF K240884 - Glide (91000-GL-X), Glide Medical Device Identification - fda.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K240884 | Class II | Active |
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Manufacturer
- Manufacturer
- Infinite Biomedical Technologies LLC
- FDA Applicant
- Infinite Biomedical Technologies, LLC
Sources (2)
- FDA 510(k) K240884 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026