Nerve and Muscle Stimulator
by Shenzhen Xft Medical Limited FDA registration: China 510(k)
510(k) K211094 Product code IPF
Overview
This device is a Nerve and Muscle Stimulator, classified under the Physical Medicine category. It delivers controlled electrical impulses to stimulate nerves and muscles, aiding in neuromuscular rehabilitation, functional recovery, and biofeedback applications. The device is designed to assist in restoring motor function, improving muscle strength, and facilitating therapeutic interventions for conditions affecting nerve or muscle integrity.
The Nerve and Muscle Stimulator is intended for use in clinical and home-based rehabilitation settings. It is supplied as a reusable medical device, adhering to FDA 510(k) clearance under the Traditional pathway, with a K-number K211094. No specific sterility or single-use designation is stated in the regulatory submission. The device operates under MRI safety guidelines as defined by its classification, though explicit MRI compatibility details are not provided. Storage and handling follow standard medical device protocols as outlined in the manufacturer’s instructions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211094 | Date8 Jul 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
Other devices from Shenzhen Xft Medical Limited
Questions
Is this device meant for use in both clinical and home settings, and if so, what makes it suitable for home use?
Yes, this Nerve and Muscle Stimulator is designed for use in both clinical and home-based rehabilitation settings. Its suitability for home use stems from its role in neuromuscular rehabilitation and functional recovery, which are common goals for patients recovering at home. The device delivers controlled electrical impulses to stimulate nerves and muscles, aiding in restoring motor function and improving muscle strength—tasks that can be safely and effectively performed under supervision or independently at home with proper guidance.
How is this device supplied, and does it require any special handling or storage instructions?
This Nerve and Muscle Stimulator is supplied as a reusable medical device, meaning it is intended for repeated use after proper cleaning and maintenance. While the regulatory submission does not specify sterility requirements, standard medical device protocols for storage and handling should be followed as outlined in the manufacturer’s instructions. This typically includes keeping the device in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring it is stored in its original packaging or a designated case when not in use.
What safety considerations should be kept in mind when using this device, particularly regarding MRI compatibility?
The device is classified under MRI safety guidelines as defined by its category, but the exact level of MRI compatibility (e.g., whether it is MRI-safe, MRI-conditional, or not for use in an MRI environment) is not explicitly detailed in the provided data. Clinicians should consult the manufacturer’s instructions for precise MRI safety information before using this device in proximity to MRI machines. Standard precautions for electrical medical devices, such as avoiding exposure to moisture or damage, should also be observed.
What are the key differences between this device and others in the Physical Medicine category, particularly in terms of its intended applications?
This Nerve and Muscle Stimulator is specifically designed to deliver controlled electrical impulses for neuromuscular rehabilitation, functional recovery, and biofeedback applications. Unlike some other devices in the Physical Medicine category that may focus solely on pain management or muscle relaxation, this one emphasizes restoring motor function and improving muscle strength through targeted nerve and muscle stimulation. Its versatility makes it suitable for a range of therapeutic interventions, including post-injury recovery, neurological conditions, or muscle atrophy.
How can I verify the regulatory status of this device, and what does the K-number (K211094) signify?
The device holds FDA 510(k) clearance under the Traditional pathway, with a K-number of K211094, indicating it has been deemed substantially equivalent to a legally marketed predicate device. The K-number is a unique identifier used by the FDA to track submissions and can be verified through the FDA’s Premarket Notification (510(k)) Database (searchable by K-number or device name). This clearance confirms the device meets FDA requirements for safety and effectiveness in its intended use as a Nerve and Muscle Stimulator.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K211094