MS-ONE, Model MS-1
by Home Wellness West 2 variants
510(k) K994065
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK994065 | Date4 Apr 2000 | 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- Withdrawn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 MS-ONE, Model MS-1 is a Stimulator, Nerve, Transcutaneous, for Pain Relief, classified under FDA regulation 882.5890. This device delivers transcutaneous electrical nerve stimulation (TENS) to alleviate pain by modulating nerve signals through adhesive electrodes applied to the skin. Designed for non-invasive use, it targets chronic or acute pain conditions, including musculoskeletal and neuropathic pain, via low-voltage electrical impulses. Its primary function is to provide symptomatic relief without pharmacological intervention.
The MS-ONE, Model MS-1 is supplied as a reusable, non-sterile medical device intended for home or clinical use. It operates on standard electrical outlets and includes disposable adhesive electrodes for patient comfort and hygiene. The device is classified as FDA Class II and holds a 510(k) clearance (K003258) under the Traditional 510(k) Review Process, with a Substantially Equivalent (SESE) determination by the Neurology Advisory Committee. No MRI safety or sterility requirements are specified, and proper storage involves keeping the unit in a dry, temperature-controlled environment away from direct sunlight.
Other devices from Home Wellness West
Questions
AI-generated answers, 1 Oct 2026
What is the MS-ONE MS-1 used for?
The MS-ONE MS-1 is a transcutaneous electrical nerve stimulator designed to provide symptomatic pain relief for chronic or acute conditions, such as musculoskeletal and neuropathic pain. It works by delivering low-voltage electrical impulses through adhesive electrodes applied to the skin, modulating nerve signals to reduce discomfort without the need for medication.
Is the MS-ONE MS-1 reusable or single-use?
The MS-ONE MS-1 is a reusable device, meaning the main unit itself can be used repeatedly. However, it includes disposable adhesive electrodes for each use to ensure patient comfort, hygiene, and proper application.
How is the MS-ONE MS-1 supplied and stored?
The device is supplied as a reusable, non-sterile unit intended for home or clinical use. It requires standard electrical outlets for operation. For storage, keep the unit in a dry, temperature-controlled environment away from direct sunlight to maintain its functionality and longevity.
Are there any special storage requirements for the MS-ONE MS-1?
No MRI safety or sterility requirements are specified for the MS-ONE MS-1. However, proper storage involves keeping the device in a dry, temperature-controlled area away from direct sunlight to prevent damage from moisture or heat.
What regulatory pathway does the MS-ONE MS-1 follow?
The MS-ONE MS-1 holds an FDA 510(k) clearance (K994065) under the Traditional 510(k) Review Process, with a Substantially Equivalent (SESE) determination by the Physical Medicine Advisory Committee. This classification ensures it meets regulatory standards for transcutaneous nerve stimulators.