Neuro-Care 1000
510(k) K926265
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK926265 | Date3 Aug 1993 | 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- Withdrawn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
- IPF
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Neuro-Care 1000 is a physical medicine device designed for neuromuscular electrical stimulation (NMES). It delivers controlled electrical impulses to stimulate muscles, aiding in rehabilitation, pain management, and muscle strengthening under medical supervision. This device is classified under the Physical Medicine category and is intended for therapeutic applications requiring precise electrical stimulation parameters.
The Neuro-Care 1000 is supplied as a reusable medical device and is regulated under the FDA’s 510(k) clearance process, classified as substantially equivalent to a predicate device. It is intended for use in clinical settings such as physical therapy offices, rehabilitation centers, and home healthcare environments. The device requires proper storage and maintenance to ensure functionality and safety, adhering to manufacturer guidelines and regulatory standards.
Questions
AI-generated answers, 1 Oct 2026
What is the Neuro-Care 1000 used for?
The Neuro-Care 1000 is designed for neuromuscular electrical stimulation (NMES), providing controlled electrical impulses to stimulate muscles. It supports rehabilitation, pain management, and muscle strengthening under medical supervision, making it suitable for physical therapy offices, rehabilitation centers, and home healthcare settings.
Is the Neuro-Care 1000 a single-use or reusable device?
The Neuro-Care 1000 is a reusable medical device. It is intended for repeated use in clinical environments, provided it is properly maintained and stored according to manufacturer guidelines to ensure functionality and safety.
What regulatory pathway does the Neuro-Care 1000 follow?
The Neuro-Care 1000 is regulated under the FDA’s 510(k) clearance process, classified as substantially equivalent to a predicate device. This means it has undergone review by the FDA’s Physical Medicine advisory committee to ensure it meets safety and effectiveness standards for therapeutic electrical stimulation devices.
Where can the Neuro-Care 1000 be used?
This device is intended for use in clinical settings such as physical therapy offices, rehabilitation centers, and home healthcare environments. Its design and regulatory clearance support its application in controlled therapeutic contexts where precise electrical stimulation is required.
How should the Neuro-Care 1000 be stored?
The Neuro-Care 1000 requires proper storage and maintenance to ensure functionality and safety. While specific storage instructions are detailed in the manufacturer’s guidelines, general best practices include keeping the device in a clean, dry environment away from direct sunlight or extreme temperatures, and following any additional care protocols provided by Ems Northwest.