MS-139 Electronic Muscle Stimulator
510(k) K862487
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK862487 | Date16 Jul 1986 | 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- Withdrawn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
- SN
Overview
AI-generated summary, 19 Sep 2026
The MS-139 Electronic Muscle Stimulator is a device classified under the nomenclature category for electrical muscle stimulators (IPF). It delivers controlled electrical impulses to stimulate muscle contractions, aiding in rehabilitation, pain management, or muscle strengthening under medical supervision.
This device is supplied as a reusable medical instrument and requires no sterilisation between uses. It is intended for use in clinical or home settings by trained professionals or patients under guidance. The MS-139 holds FDA 510(k) clearance (K862487) for indications within the Physical Medicine advisory committee, with no specific MRI safety or size restrictions noted in the regulatory filing.
Other devices from Electro Med Supply, Inc.
Questions
AI-generated answers, 19 Sep 2026
Is the MS-139 Electronic Muscle Stimulator designed for single-use or can it be reused across multiple patients or sessions?
The MS-139 is explicitly labeled as a reusable medical instrument, meaning it is intended for repeated use without requiring sterilization between sessions. Since it does not require sterilization, it is suitable for both clinical and home settings where trained professionals or patients under guidance may operate it over time.
What types of clinical settings or patient needs is this device primarily intended to support, based on its FDA clearance?
The MS-139 received FDA 510(k) clearance under the Physical Medicine advisory committee, indicating its primary use is for rehabilitation, pain management, or muscle strengthening through controlled electrical stimulation. It is not restricted to specific MRI environments or patient sizes, making it versatile for general therapeutic applications.
How is the MS-139 supplied, and are there any special handling requirements for storage or maintenance?
The MS-139 is supplied as a reusable device, so no sterilization is required between uses. While the device data does not specify storage conditions, typical reusable medical instruments should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Maintenance instructions are not provided in the data, but proper care—such as cleaning per manufacturer guidelines—would be necessary to ensure safe, prolonged use.
Does the MS-139 come in different sizes or models, or is it a single-unit device?
The provided data does not mention any variations in size or model numbers for the MS-139, suggesting it is likely offered as a single-unit device without modular or adjustable components. If specific configurations are needed, they would need to be confirmed directly with Electro Med Supply, Inc.