Ultra-Garment Electrode
510(k) K993130
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993130 | Date17 Dec 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GXY
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1320
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Ultra-Garment Electrode is a reusable, stretchable, electrically conductive garment designed as an interface between a patient and electrical stimulation units. Classified under product code GXY, it functions as a wearable electrode for applications such as transcutaneous electrical nerve stimulation (TENS), high-voltage pulsed galvanic (HVPG), and interferential neuromuscular electrical stimulation (INF). Its flexible design allows for use as a glove, sock, or sleeve, ensuring adaptability to various anatomical regions.
Supplied as a reusable device, the Ultra-Garment Electrode is intended for use in clinical settings where electrical stimulation therapy is administered. It holds an FDA 510(k) clearance under the Traditional pathway, determined by the Neurology Advisory Committee as substantially equivalent to a predicate device. No specific sterility or single-use requirements are noted, and its MRI safety profile is not documented in the available data. The device is regulated under the GXY product code and is manufactured by Newwave Medical, LLC.
Other devices from Newwave Medical, LLC
Questions
AI-generated answers, 20 Sep 2026
What types of electrical stimulation therapies is the Ultra-Garment Electrode designed to work with, and how does its flexible design help in clinical use?
The Ultra-Garment Electrode is designed for transcutaneous electrical nerve stimulation (TENS), high-voltage pulsed galvanic (HVPG), and interferential neuromuscular electrical stimulation (INF) therapies. Its stretchable, wearable design allows it to conform to various anatomical regions, enabling use as a glove, sock, or sleeve for better patient comfort and adaptability during treatment.
Is the Ultra-Garment Electrode intended for single-use or reusable applications, and what does that mean for maintenance in a clinical setting?
The Ultra-Garment Electrode is explicitly described as a reusable device, meaning it is meant to be cleaned and reused between patients. In a clinical setting, this implies that proper disinfection protocols must be followed to ensure safety and hygiene, though no specific sterility requirements are noted in the available data.
What anatomical regions can the Ultra-Garment Electrode be used on, and how does its form factor differ from traditional electrode pads?
Due to its flexible, stretchable design, the Ultra-Garment Electrode can be worn as a glove, sock, or sleeve, making it adaptable to regions like hands, feet, or limbs—unlike rigid or fixed electrode pads. This allows for continuous, conforming contact during electrical stimulation therapies, improving patient fit and reducing the need for repositioning.
How was the FDA clearance for the Ultra-Garment Electrode determined, and what does the product code GXY indicate about its regulatory classification?
The Ultra-Garment Electrode received FDA clearance under the Traditional 510(k) pathway, with a decision of substantially equivalent to a predicate device, as reviewed by the Neurology Advisory Committee. The product code GXY categorizes it under electrical stimulation devices, confirming its regulatory classification as a wearable electrode system for neuromuscular or pain management applications.