Transcutaneous Elect. Nerve Stimul-Myostim 410
by Electro Therapeutic Devices, Inc.
510(k) K853719
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK853719 | Date4 Dec 1985 | 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- Withdrawn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
- GZJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Transcutaneous Electrical Nerve Stimulator Myostim 410 is a transcutaneous electrical nerve stimulation (TENS) device designed to modulate pain and muscle function through low-voltage electrical impulses delivered via surface electrodes. It falls under the category of neuromuscular electrical stimulation (NMES) devices, providing therapeutic stimulation for nerve and muscle activation. This device is intended for external application to the skin, targeting peripheral nerves and muscles to alleviate pain or promote muscle contraction. Its primary function aligns with the FDA’s classification under product code GZJ for limited-function TENS devices.
The Myostim 410 is supplied as a reusable medical device, intended for clinical and home use under professional supervision or patient self-administration. It operates with adjustable parameters for current intensity, pulse duration, and frequency to accommodate varying therapeutic needs. The device is not sterile and requires proper cleaning and maintenance between uses. No specific MRI safety information is provided, and its regulatory status is confirmed by FDA 510(k) clearance under K853719, classified as substantially equivalent under the Neurology advisory committee’s review. Storage and usage follow standard electrical medical device guidelines.
Other devices from Electro Therapeutic Devices, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Myostim 410 used for?
The Myostim 410 is a transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES) device designed to modulate pain and promote muscle contraction. It delivers low-voltage electrical impulses through surface electrodes to target peripheral nerves and muscles, making it suitable for therapeutic applications like pain relief or muscle activation. It falls under FDA’s limited-function TENS category (product code GZJ) and is intended for external skin application.
Is the Myostim 410 reusable or single-use?
The Myostim 410 is a reusable medical device, intended for both clinical and home use. It requires proper cleaning and maintenance between uses to ensure safety and efficacy. Unlike single-use devices, it is designed for repeated applications under professional supervision or patient self-administration, provided the device remains in good working condition.
How is the Myostim 410 supplied and what adjustments can be made?
The Myostim 410 is supplied as a complete reusable unit, including electrodes for external skin application. It features adjustable parameters for current intensity, pulse duration, and frequency, allowing clinicians or users to customize settings based on specific therapeutic needs. These adjustments help tailor stimulation to the patient’s requirements for pain modulation or muscle activation.
Is the Myostim 410 sterile?
No, the Myostim 410 is not a sterile device. It is designed for external application to the skin and requires proper cleaning and maintenance between uses. Sterility is not required for this type of reusable electrical stimulation device, as it does not penetrate the skin or enter sterile body areas.
What regulatory approval does the Myostim 410 have?
The Myostim 410 holds FDA 510(k) clearance under the reference number K853719. It was classified as substantially equivalent (SESE) under the Neurology advisory committee’s review, aligning with the FDA’s product code GZJ for limited-function TENS devices. This clearance confirms its compliance with regulatory standards for safety and effectiveness in its intended use.