Zinetics AMC
by Zinetics Medical, Inc. 510(k)
Active
510(k) K921682
Overview
The Zinetics AMC is a System, Gastrointestinal Motility (Electrical) as classified under FDA regulation 876.1725. This device is designed to stimulate and monitor gastrointestinal motility through electrical stimulation, aiding in the assessment and treatment of motility disorders in gastroenterology and urology.
The Zinetics AMC is supplied as a reusable medical system and is intended for use in clinical settings such as hospitals or specialized motility laboratories. It operates under FDA 510(k) clearance (K921682) and is regulated as a Class II device. No specific sterility or MRI safety information is provided in the available data, and its use is governed by the manufacturer’s instructions and regulatory compliance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK921682 | Date29 Dec 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FFX
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1725
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Zinetics Medical, Inc.
Questions
What clinical specialties is the Zinetics AMC primarily intended for, and how does it support their workflows?
The Zinetics AMC is designed for use in gastroenterology and urology specialties, as indicated by its FDA advisory committee classification (GU). It stimulates and monitors gastrointestinal motility through electrical methods, aiding in the assessment and treatment of motility disorders. Clinicians in these fields can use it to evaluate and manage conditions affecting digestive and urinary tract function, particularly in specialized motility laboratories or hospital settings.
Is the Zinetics AMC a single-use or reusable device, and what are the implications for maintenance and cleaning?
The Zinetics AMC is explicitly described as a reusable medical system, intended for clinical settings like hospitals or motility labs. Since it is reusable, proper cleaning, sterilization (if applicable), and maintenance procedures must follow the manufacturer’s instructions to ensure safety and functionality. No specific sterility details are provided, so adherence to Zinetics Medical’s guidelines is critical.
How is the Zinetics AMC regulated by the FDA, and what does its classification as a Class II device mean for its use?
The Zinetics AMC is classified as a Class II device under FDA regulation 876.1725 and holds a 510(k) clearance (K921682). This classification means it is subject to special controls to ensure its safety and effectiveness, including performance standards and post-market surveillance. While it is not a high-risk device like Class III, it still requires compliance with FDA guidelines and manufacturer instructions for proper use in clinical settings.
Are there multiple models or variations of the Zinetics AMC, and if so, how can I identify the correct one for my needs?
The provided data lists multiple FEI numbers (e.g., 3010381606, 3012480535, etc.), which likely correspond to different models or variations of the Zinetics AMC system. These identifiers are used for regulatory tracking and may reflect updates or custom configurations. To determine the correct model for your needs, consult Zinetics Medical’s documentation or contact their support team (e.g., Richard Vincins) for clarification on specifications, compatibility, or intended use cases.